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• What Is a Case Study? | Definition, Examples & Methods

What Is a Case Study? | Definition, Examples & Methods

Published on May 8, 2019 by Shona McCombes . Revised on November 20, 2023.

A case study is a detailed study of a specific subject, such as a person, group, place, event, organization, or phenomenon. Case studies are commonly used in social, educational, clinical, and business research.

A case study research design usually involves qualitative methods , but quantitative methods are sometimes also used. Case studies are good for describing , comparing, evaluating and understanding different aspects of a research problem .

Table of contents

When to do a case study, step 1: select a case, step 2: build a theoretical framework, step 3: collect your data, step 4: describe and analyze the case, other interesting articles.

A case study is an appropriate research design when you want to gain concrete, contextual, in-depth knowledge about a specific real-world subject. It allows you to explore the key characteristics, meanings, and implications of the case.

Case studies are often a good choice in a thesis or dissertation . They keep your project focused and manageable when you don’t have the time or resources to do large-scale research.

You might use just one complex case study where you explore a single subject in depth, or conduct multiple case studies to compare and illuminate different aspects of your research problem.

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Once you have developed your problem statement and research questions , you should be ready to choose the specific case that you want to focus on. A good case study should have the potential to:

• Provide new or unexpected insights into the subject
• Challenge or complicate existing assumptions and theories
• Propose practical courses of action to resolve a problem
• Open up new directions for future research

TipIf your research is more practical in nature and aims to simultaneously investigate an issue as you solve it, consider conducting action research instead.

Unlike quantitative or experimental research , a strong case study does not require a random or representative sample. In fact, case studies often deliberately focus on unusual, neglected, or outlying cases which may shed new light on the research problem.

Example of an outlying case studyIn the 1960s the town of Roseto, Pennsylvania was discovered to have extremely low rates of heart disease compared to the US average. It became an important case study for understanding previously neglected causes of heart disease.

However, you can also choose a more common or representative case to exemplify a particular category, experience or phenomenon.

Example of a representative case studyIn the 1920s, two sociologists used Muncie, Indiana as a case study of a typical American city that supposedly exemplified the changing culture of the US at the time.

While case studies focus more on concrete details than general theories, they should usually have some connection with theory in the field. This way the case study is not just an isolated description, but is integrated into existing knowledge about the topic. It might aim to:

• Exemplify a theory by showing how it explains the case under investigation
• Expand on a theory by uncovering new concepts and ideas that need to be incorporated
• Challenge a theory by exploring an outlier case that doesn’t fit with established assumptions

To ensure that your analysis of the case has a solid academic grounding, you should conduct a literature review of sources related to the topic and develop a theoretical framework . This means identifying key concepts and theories to guide your analysis and interpretation.

There are many different research methods you can use to collect data on your subject. Case studies tend to focus on qualitative data using methods such as interviews , observations , and analysis of primary and secondary sources (e.g., newspaper articles, photographs, official records). Sometimes a case study will also collect quantitative data.

Example of a mixed methods case studyFor a case study of a wind farm development in a rural area, you could collect quantitative data on employment rates and business revenue, collect qualitative data on local people’s perceptions and experiences, and analyze local and national media coverage of the development.

The aim is to gain as thorough an understanding as possible of the case and its context.

In writing up the case study, you need to bring together all the relevant aspects to give as complete a picture as possible of the subject.

How you report your findings depends on the type of research you are doing. Some case studies are structured like a standard scientific paper or thesis , with separate sections or chapters for the methods , results and discussion .

Others are written in a more narrative style, aiming to explore the case from various angles and analyze its meanings and implications (for example, by using textual analysis or discourse analysis ).

In all cases, though, make sure to give contextual details about the case, connect it back to the literature and theory, and discuss how it fits into wider patterns or debates.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

• Normal distribution
• Degrees of freedom
• Null hypothesis
• Discourse analysis
• Control groups
• Mixed methods research
• Non-probability sampling
• Quantitative research
• Ecological validity

Research bias

• Rosenthal effect
• Implicit bias
• Cognitive bias
• Selection bias
• Negativity bias
• Status quo bias

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Organizing Your Social Sciences Research Assignments

• Annotated Bibliography
• Analyzing a Scholarly Journal Article
• Group Presentations
• Dealing with Nervousness
• Using Visual Aids
• Grading Someone Else's Paper
• Types of Structured Group Activities
• Group Project Survival Skills
• Leading a Class Discussion
• Multiple Book Review Essay
• Reviewing Collected Works
• Writing a Case Analysis Paper
• Writing a Case Study
• About Informed Consent
• Writing Field Notes
• Writing a Policy Memo
• Writing a Reflective Paper
• Writing a Research Proposal
• Generative AI and Writing
• Acknowledgments

A case study research paper examines a person, place, event, condition, phenomenon, or other type of subject of analysis in order to extrapolate  key themes and results that help predict future trends, illuminate previously hidden issues that can be applied to practice, and/or provide a means for understanding an important research problem with greater clarity. A case study research paper usually examines a single subject of analysis, but case study papers can also be designed as a comparative investigation that shows relationships between two or more subjects. The methods used to study a case can rest within a quantitative, qualitative, or mixed-method investigative paradigm.

Case Studies. Writing@CSU. Colorado State University; Mills, Albert J. , Gabrielle Durepos, and Eiden Wiebe, editors. Encyclopedia of Case Study Research . Thousand Oaks, CA: SAGE Publications, 2010 ; “What is a Case Study?” In Swanborn, Peter G. Case Study Research: What, Why and How? London: SAGE, 2010.

How to Approach Writing a Case Study Research Paper

General information about how to choose a topic to investigate can be found under the " Choosing a Research Problem " tab in the Organizing Your Social Sciences Research Paper writing guide. Review this page because it may help you identify a subject of analysis that can be investigated using a case study design.

However, identifying a case to investigate involves more than choosing the research problem . A case study encompasses a problem contextualized around the application of in-depth analysis, interpretation, and discussion, often resulting in specific recommendations for action or for improving existing conditions. As Seawright and Gerring note, practical considerations such as time and access to information can influence case selection, but these issues should not be the sole factors used in describing the methodological justification for identifying a particular case to study. Given this, selecting a case includes considering the following:

• The case represents an unusual or atypical example of a research problem that requires more in-depth analysis? Cases often represent a topic that rests on the fringes of prior investigations because the case may provide new ways of understanding the research problem. For example, if the research problem is to identify strategies to improve policies that support girl's access to secondary education in predominantly Muslim nations, you could consider using Azerbaijan as a case study rather than selecting a more obvious nation in the Middle East. Doing so may reveal important new insights into recommending how governments in other predominantly Muslim nations can formulate policies that support improved access to education for girls.
• The case provides important insight or illuminate a previously hidden problem? In-depth analysis of a case can be based on the hypothesis that the case study will reveal trends or issues that have not been exposed in prior research or will reveal new and important implications for practice. For example, anecdotal evidence may suggest drug use among homeless veterans is related to their patterns of travel throughout the day. Assuming prior studies have not looked at individual travel choices as a way to study access to illicit drug use, a case study that observes a homeless veteran could reveal how issues of personal mobility choices facilitate regular access to illicit drugs. Note that it is important to conduct a thorough literature review to ensure that your assumption about the need to reveal new insights or previously hidden problems is valid and evidence-based.
• The case challenges and offers a counter-point to prevailing assumptions? Over time, research on any given topic can fall into a trap of developing assumptions based on outdated studies that are still applied to new or changing conditions or the idea that something should simply be accepted as "common sense," even though the issue has not been thoroughly tested in current practice. A case study analysis may offer an opportunity to gather evidence that challenges prevailing assumptions about a research problem and provide a new set of recommendations applied to practice that have not been tested previously. For example, perhaps there has been a long practice among scholars to apply a particular theory in explaining the relationship between two subjects of analysis. Your case could challenge this assumption by applying an innovative theoretical framework [perhaps borrowed from another discipline] to explore whether this approach offers new ways of understanding the research problem. Taking a contrarian stance is one of the most important ways that new knowledge and understanding develops from existing literature.
• The case provides an opportunity to pursue action leading to the resolution of a problem? Another way to think about choosing a case to study is to consider how the results from investigating a particular case may result in findings that reveal ways in which to resolve an existing or emerging problem. For example, studying the case of an unforeseen incident, such as a fatal accident at a railroad crossing, can reveal hidden issues that could be applied to preventative measures that contribute to reducing the chance of accidents in the future. In this example, a case study investigating the accident could lead to a better understanding of where to strategically locate additional signals at other railroad crossings so as to better warn drivers of an approaching train, particularly when visibility is hindered by heavy rain, fog, or at night.
• The case offers a new direction in future research? A case study can be used as a tool for an exploratory investigation that highlights the need for further research about the problem. A case can be used when there are few studies that help predict an outcome or that establish a clear understanding about how best to proceed in addressing a problem. For example, after conducting a thorough literature review [very important!], you discover that little research exists showing the ways in which women contribute to promoting water conservation in rural communities of east central Africa. A case study of how women contribute to saving water in a rural village of Uganda can lay the foundation for understanding the need for more thorough research that documents how women in their roles as cooks and family caregivers think about water as a valuable resource within their community. This example of a case study could also point to the need for scholars to build new theoretical frameworks around the topic [e.g., applying feminist theories of work and family to the issue of water conservation].

Eisenhardt, Kathleen M. “Building Theories from Case Study Research.” Academy of Management Review 14 (October 1989): 532-550; Emmel, Nick. Sampling and Choosing Cases in Qualitative Research: A Realist Approach . Thousand Oaks, CA: SAGE Publications, 2013; Gerring, John. “What Is a Case Study and What Is It Good for?” American Political Science Review 98 (May 2004): 341-354; Mills, Albert J. , Gabrielle Durepos, and Eiden Wiebe, editors. Encyclopedia of Case Study Research . Thousand Oaks, CA: SAGE Publications, 2010; Seawright, Jason and John Gerring. "Case Selection Techniques in Case Study Research." Political Research Quarterly 61 (June 2008): 294-308.

Structure and Writing Style

The purpose of a paper in the social sciences designed around a case study is to thoroughly investigate a subject of analysis in order to reveal a new understanding about the research problem and, in so doing, contributing new knowledge to what is already known from previous studies. In applied social sciences disciplines [e.g., education, social work, public administration, etc.], case studies may also be used to reveal best practices, highlight key programs, or investigate interesting aspects of professional work.

In general, the structure of a case study research paper is not all that different from a standard college-level research paper. However, there are subtle differences you should be aware of. Here are the key elements to organizing and writing a case study research paper.

I.  Introduction

As with any research paper, your introduction should serve as a roadmap for your readers to ascertain the scope and purpose of your study . The introduction to a case study research paper, however, should not only describe the research problem and its significance, but you should also succinctly describe why the case is being used and how it relates to addressing the problem. The two elements should be linked. With this in mind, a good introduction answers these four questions:

• What is being studied? Describe the research problem and describe the subject of analysis [the case] you have chosen to address the problem. Explain how they are linked and what elements of the case will help to expand knowledge and understanding about the problem.
• Why is this topic important to investigate? Describe the significance of the research problem and state why a case study design and the subject of analysis that the paper is designed around is appropriate in addressing the problem.
• What did we know about this topic before I did this study? Provide background that helps lead the reader into the more in-depth literature review to follow. If applicable, summarize prior case study research applied to the research problem and why it fails to adequately address the problem. Describe why your case will be useful. If no prior case studies have been used to address the research problem, explain why you have selected this subject of analysis.
• How will this study advance new knowledge or new ways of understanding? Explain why your case study will be suitable in helping to expand knowledge and understanding about the research problem.

Each of these questions should be addressed in no more than a few paragraphs. Exceptions to this can be when you are addressing a complex research problem or subject of analysis that requires more in-depth background information.

II.  Literature Review

The literature review for a case study research paper is generally structured the same as it is for any college-level research paper. The difference, however, is that the literature review is focused on providing background information and  enabling historical interpretation of the subject of analysis in relation to the research problem the case is intended to address . This includes synthesizing studies that help to:

• Place relevant works in the context of their contribution to understanding the case study being investigated . This would involve summarizing studies that have used a similar subject of analysis to investigate the research problem. If there is literature using the same or a very similar case to study, you need to explain why duplicating past research is important [e.g., conditions have changed; prior studies were conducted long ago, etc.].
• Describe the relationship each work has to the others under consideration that informs the reader why this case is applicable . Your literature review should include a description of any works that support using the case to investigate the research problem and the underlying research questions.
• Identify new ways to interpret prior research using the case study . If applicable, review any research that has examined the research problem using a different research design. Explain how your use of a case study design may reveal new knowledge or a new perspective or that can redirect research in an important new direction.
• Resolve conflicts amongst seemingly contradictory previous studies . This refers to synthesizing any literature that points to unresolved issues of concern about the research problem and describing how the subject of analysis that forms the case study can help resolve these existing contradictions.
• Point the way in fulfilling a need for additional research . Your review should examine any literature that lays a foundation for understanding why your case study design and the subject of analysis around which you have designed your study may reveal a new way of approaching the research problem or offer a perspective that points to the need for additional research.
• Expose any gaps that exist in the literature that the case study could help to fill . Summarize any literature that not only shows how your subject of analysis contributes to understanding the research problem, but how your case contributes to a new way of understanding the problem that prior research has failed to do.
• Locate your own research within the context of existing literature [very important!] . Collectively, your literature review should always place your case study within the larger domain of prior research about the problem. The overarching purpose of reviewing pertinent literature in a case study paper is to demonstrate that you have thoroughly identified and synthesized prior studies in relation to explaining the relevance of the case in addressing the research problem.

III.  Method

In this section, you explain why you selected a particular case [i.e., subject of analysis] and the strategy you used to identify and ultimately decide that your case was appropriate in addressing the research problem. The way you describe the methods used varies depending on the type of subject of analysis that constitutes your case study.

If your subject of analysis is an incident or event . In the social and behavioral sciences, the event or incident that represents the case to be studied is usually bounded by time and place, with a clear beginning and end and with an identifiable location or position relative to its surroundings. The subject of analysis can be a rare or critical event or it can focus on a typical or regular event. The purpose of studying a rare event is to illuminate new ways of thinking about the broader research problem or to test a hypothesis. Critical incident case studies must describe the method by which you identified the event and explain the process by which you determined the validity of this case to inform broader perspectives about the research problem or to reveal new findings. However, the event does not have to be a rare or uniquely significant to support new thinking about the research problem or to challenge an existing hypothesis. For example, Walo, Bull, and Breen conducted a case study to identify and evaluate the direct and indirect economic benefits and costs of a local sports event in the City of Lismore, New South Wales, Australia. The purpose of their study was to provide new insights from measuring the impact of a typical local sports event that prior studies could not measure well because they focused on large "mega-events." Whether the event is rare or not, the methods section should include an explanation of the following characteristics of the event: a) when did it take place; b) what were the underlying circumstances leading to the event; and, c) what were the consequences of the event in relation to the research problem.

If your subject of analysis is a person. Explain why you selected this particular individual to be studied and describe what experiences they have had that provide an opportunity to advance new understandings about the research problem. Mention any background about this person which might help the reader understand the significance of their experiences that make them worthy of study. This includes describing the relationships this person has had with other people, institutions, and/or events that support using them as the subject for a case study research paper. It is particularly important to differentiate the person as the subject of analysis from others and to succinctly explain how the person relates to examining the research problem [e.g., why is one politician in a particular local election used to show an increase in voter turnout from any other candidate running in the election]. Note that these issues apply to a specific group of people used as a case study unit of analysis [e.g., a classroom of students].

If your subject of analysis is a place. In general, a case study that investigates a place suggests a subject of analysis that is unique or special in some way and that this uniqueness can be used to build new understanding or knowledge about the research problem. A case study of a place must not only describe its various attributes relevant to the research problem [e.g., physical, social, historical, cultural, economic, political], but you must state the method by which you determined that this place will illuminate new understandings about the research problem. It is also important to articulate why a particular place as the case for study is being used if similar places also exist [i.e., if you are studying patterns of homeless encampments of veterans in open spaces, explain why you are studying Echo Park in Los Angeles rather than Griffith Park?]. If applicable, describe what type of human activity involving this place makes it a good choice to study [e.g., prior research suggests Echo Park has more homeless veterans].

If your subject of analysis is a phenomenon. A phenomenon refers to a fact, occurrence, or circumstance that can be studied or observed but with the cause or explanation to be in question. In this sense, a phenomenon that forms your subject of analysis can encompass anything that can be observed or presumed to exist but is not fully understood. In the social and behavioral sciences, the case usually focuses on human interaction within a complex physical, social, economic, cultural, or political system. For example, the phenomenon could be the observation that many vehicles used by ISIS fighters are small trucks with English language advertisements on them. The research problem could be that ISIS fighters are difficult to combat because they are highly mobile. The research questions could be how and by what means are these vehicles used by ISIS being supplied to the militants and how might supply lines to these vehicles be cut off? How might knowing the suppliers of these trucks reveal larger networks of collaborators and financial support? A case study of a phenomenon most often encompasses an in-depth analysis of a cause and effect that is grounded in an interactive relationship between people and their environment in some way.

NOTE:   The choice of the case or set of cases to study cannot appear random. Evidence that supports the method by which you identified and chose your subject of analysis should clearly support investigation of the research problem and linked to key findings from your literature review. Be sure to cite any studies that helped you determine that the case you chose was appropriate for examining the problem.

IV.  Discussion

The main elements of your discussion section are generally the same as any research paper, but centered around interpreting and drawing conclusions about the key findings from your analysis of the case study. Note that a general social sciences research paper may contain a separate section to report findings. However, in a paper designed around a case study, it is common to combine a description of the results with the discussion about their implications. The objectives of your discussion section should include the following:

Reiterate the Research Problem/State the Major Findings Briefly reiterate the research problem you are investigating and explain why the subject of analysis around which you designed the case study were used. You should then describe the findings revealed from your study of the case using direct, declarative, and succinct proclamation of the study results. Highlight any findings that were unexpected or especially profound.

Explain the Meaning of the Findings and Why They are Important Systematically explain the meaning of your case study findings and why you believe they are important. Begin this part of the section by repeating what you consider to be your most important or surprising finding first, then systematically review each finding. Be sure to thoroughly extrapolate what your analysis of the case can tell the reader about situations or conditions beyond the actual case that was studied while, at the same time, being careful not to misconstrue or conflate a finding that undermines the external validity of your conclusions.

Relate the Findings to Similar Studies No study in the social sciences is so novel or possesses such a restricted focus that it has absolutely no relation to previously published research. The discussion section should relate your case study results to those found in other studies, particularly if questions raised from prior studies served as the motivation for choosing your subject of analysis. This is important because comparing and contrasting the findings of other studies helps support the overall importance of your results and it highlights how and in what ways your case study design and the subject of analysis differs from prior research about the topic.

Consider Alternative Explanations of the Findings Remember that the purpose of social science research is to discover and not to prove. When writing the discussion section, you should carefully consider all possible explanations revealed by the case study results, rather than just those that fit your hypothesis or prior assumptions and biases. Be alert to what the in-depth analysis of the case may reveal about the research problem, including offering a contrarian perspective to what scholars have stated in prior research if that is how the findings can be interpreted from your case.

Acknowledge the Study's Limitations You can state the study's limitations in the conclusion section of your paper but describing the limitations of your subject of analysis in the discussion section provides an opportunity to identify the limitations and explain why they are not significant. This part of the discussion section should also note any unanswered questions or issues your case study could not address. More detailed information about how to document any limitations to your research can be found here .

Suggest Areas for Further Research Although your case study may offer important insights about the research problem, there are likely additional questions related to the problem that remain unanswered or findings that unexpectedly revealed themselves as a result of your in-depth analysis of the case. Be sure that the recommendations for further research are linked to the research problem and that you explain why your recommendations are valid in other contexts and based on the original assumptions of your study.

V.  Conclusion

As with any research paper, you should summarize your conclusion in clear, simple language; emphasize how the findings from your case study differs from or supports prior research and why. Do not simply reiterate the discussion section. Provide a synthesis of key findings presented in the paper to show how these converge to address the research problem. If you haven't already done so in the discussion section, be sure to document the limitations of your case study and any need for further research.

The function of your paper's conclusion is to: 1) reiterate the main argument supported by the findings from your case study; 2) state clearly the context, background, and necessity of pursuing the research problem using a case study design in relation to an issue, controversy, or a gap found from reviewing the literature; and, 3) provide a place to persuasively and succinctly restate the significance of your research problem, given that the reader has now been presented with in-depth information about the topic.

Consider the following points to help ensure your conclusion is appropriate:

• If the argument or purpose of your paper is complex, you may need to summarize these points for your reader.
• If prior to your conclusion, you have not yet explained the significance of your findings or if you are proceeding inductively, use the conclusion of your paper to describe your main points and explain their significance.
• Move from a detailed to a general level of consideration of the case study's findings that returns the topic to the context provided by the introduction or within a new context that emerges from your case study findings.

Note that, depending on the discipline you are writing in or the preferences of your professor, the concluding paragraph may contain your final reflections on the evidence presented as it applies to practice or on the essay's central research problem. However, the nature of being introspective about the subject of analysis you have investigated will depend on whether you are explicitly asked to express your observations in this way.

Problems to Avoid

Overgeneralization One of the goals of a case study is to lay a foundation for understanding broader trends and issues applied to similar circumstances. However, be careful when drawing conclusions from your case study. They must be evidence-based and grounded in the results of the study; otherwise, it is merely speculation. Looking at a prior example, it would be incorrect to state that a factor in improving girls access to education in Azerbaijan and the policy implications this may have for improving access in other Muslim nations is due to girls access to social media if there is no documentary evidence from your case study to indicate this. There may be anecdotal evidence that retention rates were better for girls who were engaged with social media, but this observation would only point to the need for further research and would not be a definitive finding if this was not a part of your original research agenda.

Failure to Document Limitations No case is going to reveal all that needs to be understood about a research problem. Therefore, just as you have to clearly state the limitations of a general research study , you must describe the specific limitations inherent in the subject of analysis. For example, the case of studying how women conceptualize the need for water conservation in a village in Uganda could have limited application in other cultural contexts or in areas where fresh water from rivers or lakes is plentiful and, therefore, conservation is understood more in terms of managing access rather than preserving access to a scarce resource.

Failure to Extrapolate All Possible Implications Just as you don't want to over-generalize from your case study findings, you also have to be thorough in the consideration of all possible outcomes or recommendations derived from your findings. If you do not, your reader may question the validity of your analysis, particularly if you failed to document an obvious outcome from your case study research. For example, in the case of studying the accident at the railroad crossing to evaluate where and what types of warning signals should be located, you failed to take into consideration speed limit signage as well as warning signals. When designing your case study, be sure you have thoroughly addressed all aspects of the problem and do not leave gaps in your analysis that leave the reader questioning the results.

Case Studies. Writing@CSU. Colorado State University; Gerring, John. Case Study Research: Principles and Practices . New York: Cambridge University Press, 2007; Merriam, Sharan B. Qualitative Research and Case Study Applications in Education . Rev. ed. San Francisco, CA: Jossey-Bass, 1998; Miller, Lisa L. “The Use of Case Studies in Law and Social Science Research.” Annual Review of Law and Social Science 14 (2018): TBD; Mills, Albert J., Gabrielle Durepos, and Eiden Wiebe, editors. Encyclopedia of Case Study Research . Thousand Oaks, CA: SAGE Publications, 2010; Putney, LeAnn Grogan. "Case Study." In Encyclopedia of Research Design , Neil J. Salkind, editor. (Thousand Oaks, CA: SAGE Publications, 2010), pp. 116-120; Simons, Helen. Case Study Research in Practice . London: SAGE Publications, 2009;  Kratochwill,  Thomas R. and Joel R. Levin, editors. Single-Case Research Design and Analysis: New Development for Psychology and Education .  Hilldsale, NJ: Lawrence Erlbaum Associates, 1992; Swanborn, Peter G. Case Study Research: What, Why and How? London : SAGE, 2010; Yin, Robert K. Case Study Research: Design and Methods . 6th edition. Los Angeles, CA, SAGE Publications, 2014; Walo, Maree, Adrian Bull, and Helen Breen. “Achieving Economic Benefits at Local Events: A Case Study of a Local Sports Event.” Festival Management and Event Tourism 4 (1996): 95-106.

Writing Tip

At Least Five Misconceptions about Case Study Research

Social science case studies are often perceived as limited in their ability to create new knowledge because they are not randomly selected and findings cannot be generalized to larger populations. Flyvbjerg examines five misunderstandings about case study research and systematically "corrects" each one. To quote, these are:

Misunderstanding 1 :  General, theoretical [context-independent] knowledge is more valuable than concrete, practical [context-dependent] knowledge. Misunderstanding 2 :  One cannot generalize on the basis of an individual case; therefore, the case study cannot contribute to scientific development. Misunderstanding 3 :  The case study is most useful for generating hypotheses; that is, in the first stage of a total research process, whereas other methods are more suitable for hypotheses testing and theory building. Misunderstanding 4 :  The case study contains a bias toward verification, that is, a tendency to confirm the researcher’s preconceived notions. Misunderstanding 5 :  It is often difficult to summarize and develop general propositions and theories on the basis of specific case studies [p. 221].

While writing your paper, think introspectively about how you addressed these misconceptions because to do so can help you strengthen the validity and reliability of your research by clarifying issues of case selection, the testing and challenging of existing assumptions, the interpretation of key findings, and the summation of case outcomes. Think of a case study research paper as a complete, in-depth narrative about the specific properties and key characteristics of your subject of analysis applied to the research problem.

Flyvbjerg, Bent. “Five Misunderstandings About Case-Study Research.” Qualitative Inquiry 12 (April 2006): 219-245.

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The Ultimate Guide to Qualitative Research - Part 1: The Basics

• Introduction and overview
• What is qualitative research?
• What is qualitative data?
• Examples of qualitative data
• Qualitative vs. quantitative research
• Mixed methods
• Qualitative research preparation
• Theoretical perspective
• Theoretical framework
• Literature reviews

Research question

• Conceptual framework
• Conceptual vs. theoretical framework

Data collection

• Qualitative research methods
• Focus groups
• Observational research

What is a case study?

Applications for case study research, what is a good case study, process of case study design, benefits and limitations of case studies.

• Ethnographical research
• Ethical considerations
• Confidentiality and privacy
• Power dynamics
• Reflexivity

Case studies

Case studies are essential to qualitative research , offering a lens through which researchers can investigate complex phenomena within their real-life contexts. This chapter explores the concept, purpose, applications, examples, and types of case studies and provides guidance on how to conduct case study research effectively.

Whereas quantitative methods look at phenomena at scale, case study research looks at a concept or phenomenon in considerable detail. While analyzing a single case can help understand one perspective regarding the object of research inquiry, analyzing multiple cases can help obtain a more holistic sense of the topic or issue. Let's provide a basic definition of a case study, then explore its characteristics and role in the qualitative research process.

Definition of a case study

A case study in qualitative research is a strategy of inquiry that involves an in-depth investigation of a phenomenon within its real-world context. It provides researchers with the opportunity to acquire an in-depth understanding of intricate details that might not be as apparent or accessible through other methods of research. The specific case or cases being studied can be a single person, group, or organization – demarcating what constitutes a relevant case worth studying depends on the researcher and their research question .

Among qualitative research methods , a case study relies on multiple sources of evidence, such as documents, artifacts, interviews , or observations , to present a complete and nuanced understanding of the phenomenon under investigation. The objective is to illuminate the readers' understanding of the phenomenon beyond its abstract statistical or theoretical explanations.

Characteristics of case studies

Case studies typically possess a number of distinct characteristics that set them apart from other research methods. These characteristics include a focus on holistic description and explanation, flexibility in the design and data collection methods, reliance on multiple sources of evidence, and emphasis on the context in which the phenomenon occurs.

Furthermore, case studies can often involve a longitudinal examination of the case, meaning they study the case over a period of time. These characteristics allow case studies to yield comprehensive, in-depth, and richly contextualized insights about the phenomenon of interest.

The role of case studies in research

Case studies hold a unique position in the broader landscape of research methods aimed at theory development. They are instrumental when the primary research interest is to gain an intensive, detailed understanding of a phenomenon in its real-life context.

In addition, case studies can serve different purposes within research - they can be used for exploratory, descriptive, or explanatory purposes, depending on the research question and objectives. This flexibility and depth make case studies a valuable tool in the toolkit of qualitative researchers.

Remember, a well-conducted case study can offer a rich, insightful contribution to both academic and practical knowledge through theory development or theory verification, thus enhancing our understanding of complex phenomena in their real-world contexts.

What is the purpose of a case study?

Case study research aims for a more comprehensive understanding of phenomena, requiring various research methods to gather information for qualitative analysis . Ultimately, a case study can allow the researcher to gain insight into a particular object of inquiry and develop a theoretical framework relevant to the research inquiry.

Why use case studies in qualitative research?

Using case studies as a research strategy depends mainly on the nature of the research question and the researcher's access to the data.

Conducting case study research provides a level of detail and contextual richness that other research methods might not offer. They are beneficial when there's a need to understand complex social phenomena within their natural contexts.

The explanatory, exploratory, and descriptive roles of case studies

Case studies can take on various roles depending on the research objectives. They can be exploratory when the research aims to discover new phenomena or define new research questions; they are descriptive when the objective is to depict a phenomenon within its context in a detailed manner; and they can be explanatory if the goal is to understand specific relationships within the studied context. Thus, the versatility of case studies allows researchers to approach their topic from different angles, offering multiple ways to uncover and interpret the data .

The impact of case studies on knowledge development

Case studies play a significant role in knowledge development across various disciplines. Analysis of cases provides an avenue for researchers to explore phenomena within their context based on the collected data.

This can result in the production of rich, practical insights that can be instrumental in both theory-building and practice. Case studies allow researchers to delve into the intricacies and complexities of real-life situations, uncovering insights that might otherwise remain hidden.

Types of case studies

In qualitative research , a case study is not a one-size-fits-all approach. Depending on the nature of the research question and the specific objectives of the study, researchers might choose to use different types of case studies. These types differ in their focus, methodology, and the level of detail they provide about the phenomenon under investigation.

Understanding these types is crucial for selecting the most appropriate approach for your research project and effectively achieving your research goals. Let's briefly look at the main types of case studies.

Exploratory case studies

Exploratory case studies are typically conducted to develop a theory or framework around an understudied phenomenon. They can also serve as a precursor to a larger-scale research project. Exploratory case studies are useful when a researcher wants to identify the key issues or questions which can spur more extensive study or be used to develop propositions for further research. These case studies are characterized by flexibility, allowing researchers to explore various aspects of a phenomenon as they emerge, which can also form the foundation for subsequent studies.

Descriptive case studies

Descriptive case studies aim to provide a complete and accurate representation of a phenomenon or event within its context. These case studies are often based on an established theoretical framework, which guides how data is collected and analyzed. The researcher is concerned with describing the phenomenon in detail, as it occurs naturally, without trying to influence or manipulate it.

Explanatory case studies

Explanatory case studies are focused on explanation - they seek to clarify how or why certain phenomena occur. Often used in complex, real-life situations, they can be particularly valuable in clarifying causal relationships among concepts and understanding the interplay between different factors within a specific context.

Intrinsic, instrumental, and collective case studies

These three categories of case studies focus on the nature and purpose of the study. An intrinsic case study is conducted when a researcher has an inherent interest in the case itself. Instrumental case studies are employed when the case is used to provide insight into a particular issue or phenomenon. A collective case study, on the other hand, involves studying multiple cases simultaneously to investigate some general phenomena.

Each type of case study serves a different purpose and has its own strengths and challenges. The selection of the type should be guided by the research question and objectives, as well as the context and constraints of the research.

The flexibility, depth, and contextual richness offered by case studies make this approach an excellent research method for various fields of study. They enable researchers to investigate real-world phenomena within their specific contexts, capturing nuances that other research methods might miss. Across numerous fields, case studies provide valuable insights into complex issues.

Critical information systems research

Case studies provide a detailed understanding of the role and impact of information systems in different contexts. They offer a platform to explore how information systems are designed, implemented, and used and how they interact with various social, economic, and political factors. Case studies in this field often focus on examining the intricate relationship between technology, organizational processes, and user behavior, helping to uncover insights that can inform better system design and implementation.

Health research

Health research is another field where case studies are highly valuable. They offer a way to explore patient experiences, healthcare delivery processes, and the impact of various interventions in a real-world context.

Case studies can provide a deep understanding of a patient's journey, giving insights into the intricacies of disease progression, treatment effects, and the psychosocial aspects of health and illness.

Asthma research studies

Specifically within medical research, studies on asthma often employ case studies to explore the individual and environmental factors that influence asthma development, management, and outcomes. A case study can provide rich, detailed data about individual patients' experiences, from the triggers and symptoms they experience to the effectiveness of various management strategies. This can be crucial for developing patient-centered asthma care approaches.

Other fields

Apart from the fields mentioned, case studies are also extensively used in business and management research, education research, and political sciences, among many others. They provide an opportunity to delve into the intricacies of real-world situations, allowing for a comprehensive understanding of various phenomena.

Case studies, with their depth and contextual focus, offer unique insights across these varied fields. They allow researchers to illuminate the complexities of real-life situations, contributing to both theory and practice.

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Understanding the key elements of case study design is crucial for conducting rigorous and impactful case study research. A well-structured design guides the researcher through the process, ensuring that the study is methodologically sound and its findings are reliable and valid. The main elements of case study design include the research question , propositions, units of analysis, and the logic linking the data to the propositions.

The research question is the foundation of any research study. A good research question guides the direction of the study and informs the selection of the case, the methods of collecting data, and the analysis techniques. A well-formulated research question in case study research is typically clear, focused, and complex enough to merit further detailed examination of the relevant case(s).

Propositions

Propositions, though not necessary in every case study, provide a direction by stating what we might expect to find in the data collected. They guide how data is collected and analyzed by helping researchers focus on specific aspects of the case. They are particularly important in explanatory case studies, which seek to understand the relationships among concepts within the studied phenomenon.

Units of analysis

The unit of analysis refers to the case, or the main entity or entities that are being analyzed in the study. In case study research, the unit of analysis can be an individual, a group, an organization, a decision, an event, or even a time period. It's crucial to clearly define the unit of analysis, as it shapes the qualitative data analysis process by allowing the researcher to analyze a particular case and synthesize analysis across multiple case studies to draw conclusions.

Argumentation

This refers to the inferential model that allows researchers to draw conclusions from the data. The researcher needs to ensure that there is a clear link between the data, the propositions (if any), and the conclusions drawn. This argumentation is what enables the researcher to make valid and credible inferences about the phenomenon under study.

Understanding and carefully considering these elements in the design phase of a case study can significantly enhance the quality of the research. It can help ensure that the study is methodologically sound and its findings contribute meaningful insights about the case.

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Conducting a case study involves several steps, from defining the research question and selecting the case to collecting and analyzing data . This section outlines these key stages, providing a practical guide on how to conduct case study research.

Defining the research question

The first step in case study research is defining a clear, focused research question. This question should guide the entire research process, from case selection to analysis. It's crucial to ensure that the research question is suitable for a case study approach. Typically, such questions are exploratory or descriptive in nature and focus on understanding a phenomenon within its real-life context.

Selecting and defining the case

The selection of the case should be based on the research question and the objectives of the study. It involves choosing a unique example or a set of examples that provide rich, in-depth data about the phenomenon under investigation. After selecting the case, it's crucial to define it clearly, setting the boundaries of the case, including the time period and the specific context.

Previous research can help guide the case study design. When considering a case study, an example of a case could be taken from previous case study research and used to define cases in a new research inquiry. Considering recently published examples can help understand how to select and define cases effectively.

Developing a detailed case study protocol

A case study protocol outlines the procedures and general rules to be followed during the case study. This includes the data collection methods to be used, the sources of data, and the procedures for analysis. Having a detailed case study protocol ensures consistency and reliability in the study.

The protocol should also consider how to work with the people involved in the research context to grant the research team access to collecting data. As mentioned in previous sections of this guide, establishing rapport is an essential component of qualitative research as it shapes the overall potential for collecting and analyzing data.

Collecting data

Gathering data in case study research often involves multiple sources of evidence, including documents, archival records, interviews, observations, and physical artifacts. This allows for a comprehensive understanding of the case. The process for gathering data should be systematic and carefully documented to ensure the reliability and validity of the study.

Analyzing and interpreting data

The next step is analyzing the data. This involves organizing the data , categorizing it into themes or patterns , and interpreting these patterns to answer the research question. The analysis might also involve comparing the findings with prior research or theoretical propositions.

Writing the case study report

The final step is writing the case study report . This should provide a detailed description of the case, the data, the analysis process, and the findings. The report should be clear, organized, and carefully written to ensure that the reader can understand the case and the conclusions drawn from it.

Each of these steps is crucial in ensuring that the case study research is rigorous, reliable, and provides valuable insights about the case.

The type, depth, and quality of data in your study can significantly influence the validity and utility of the study. In case study research, data is usually collected from multiple sources to provide a comprehensive and nuanced understanding of the case. This section will outline the various methods of collecting data used in case study research and discuss considerations for ensuring the quality of the data.

Interviews are a common method of gathering data in case study research. They can provide rich, in-depth data about the perspectives, experiences, and interpretations of the individuals involved in the case. Interviews can be structured , semi-structured , or unstructured , depending on the research question and the degree of flexibility needed.

Observations

Observations involve the researcher observing the case in its natural setting, providing first-hand information about the case and its context. Observations can provide data that might not be revealed in interviews or documents, such as non-verbal cues or contextual information.

Documents and artifacts

Documents and archival records provide a valuable source of data in case study research. They can include reports, letters, memos, meeting minutes, email correspondence, and various public and private documents related to the case.

These records can provide historical context, corroborate evidence from other sources, and offer insights into the case that might not be apparent from interviews or observations.

Physical artifacts refer to any physical evidence related to the case, such as tools, products, or physical environments. These artifacts can provide tangible insights into the case, complementing the data gathered from other sources.

Ensuring the quality of data collection

Determining the quality of data in case study research requires careful planning and execution. It's crucial to ensure that the data is reliable, accurate, and relevant to the research question. This involves selecting appropriate methods of collecting data, properly training interviewers or observers, and systematically recording and storing the data. It also includes considering ethical issues related to collecting and handling data, such as obtaining informed consent and ensuring the privacy and confidentiality of the participants.

Data analysis

Analyzing case study research involves making sense of the rich, detailed data to answer the research question. This process can be challenging due to the volume and complexity of case study data. However, a systematic and rigorous approach to analysis can ensure that the findings are credible and meaningful. This section outlines the main steps and considerations in analyzing data in case study research.

Organizing the data

The first step in the analysis is organizing the data. This involves sorting the data into manageable sections, often according to the data source or the theme. This step can also involve transcribing interviews, digitizing physical artifacts, or organizing observational data.

Categorizing and coding the data

Once the data is organized, the next step is to categorize or code the data. This involves identifying common themes, patterns, or concepts in the data and assigning codes to relevant data segments. Coding can be done manually or with the help of software tools, and in either case, qualitative analysis software can greatly facilitate the entire coding process. Coding helps to reduce the data to a set of themes or categories that can be more easily analyzed.

Identifying patterns and themes

After coding the data, the researcher looks for patterns or themes in the coded data. This involves comparing and contrasting the codes and looking for relationships or patterns among them. The identified patterns and themes should help answer the research question.

Interpreting the data

Once patterns and themes have been identified, the next step is to interpret these findings. This involves explaining what the patterns or themes mean in the context of the research question and the case. This interpretation should be grounded in the data, but it can also involve drawing on theoretical concepts or prior research.

Verification of the data

The last step in the analysis is verification. This involves checking the accuracy and consistency of the analysis process and confirming that the findings are supported by the data. This can involve re-checking the original data, checking the consistency of codes, or seeking feedback from research participants or peers.

Like any research method , case study research has its strengths and limitations. Researchers must be aware of these, as they can influence the design, conduct, and interpretation of the study.

Understanding the strengths and limitations of case study research can also guide researchers in deciding whether this approach is suitable for their research question . This section outlines some of the key strengths and limitations of case study research.

Benefits include the following:

• Rich, detailed data: One of the main strengths of case study research is that it can generate rich, detailed data about the case. This can provide a deep understanding of the case and its context, which can be valuable in exploring complex phenomena.
• Flexibility: Case study research is flexible in terms of design , data collection , and analysis . A sufficient degree of flexibility allows the researcher to adapt the study according to the case and the emerging findings.
• Real-world context: Case study research involves studying the case in its real-world context, which can provide valuable insights into the interplay between the case and its context.
• Multiple sources of evidence: Case study research often involves collecting data from multiple sources , which can enhance the robustness and validity of the findings.

On the other hand, researchers should consider the following limitations:

• Generalizability: A common criticism of case study research is that its findings might not be generalizable to other cases due to the specificity and uniqueness of each case.
• Time and resource intensive: Case study research can be time and resource intensive due to the depth of the investigation and the amount of collected data.
• Complexity of analysis: The rich, detailed data generated in case study research can make analyzing the data challenging.
• Subjectivity: Given the nature of case study research, there may be a higher degree of subjectivity in interpreting the data , so researchers need to reflect on this and transparently convey to audiences how the research was conducted.

Being aware of these strengths and limitations can help researchers design and conduct case study research effectively and interpret and report the findings appropriately.

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What is case study research?

Last updated

8 February 2023

Reviewed by

Cathy Heath

Suppose a company receives a spike in the number of customer complaints, or medical experts discover an outbreak of illness affecting children but are not quite sure of the reason. In both cases, carrying out a case study could be the best way to get answers.

Organization

Case studies can be carried out across different disciplines, including education, medicine, sociology, and business.

Most case studies employ qualitative methods, but quantitative methods can also be used. Researchers can then describe, compare, evaluate, and identify patterns or cause-and-effect relationships between the various variables under study. They can then use this knowledge to decide what action to take. 

Another thing to note is that case studies are generally singular in their focus. This means they narrow focus to a particular area, making them highly subjective. You cannot always generalize the results of a case study and apply them to a larger population. However, they are valuable tools to illustrate a principle or develop a thesis.

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• What are the different types of case study designs?

Researchers can choose from a variety of case study designs. The design they choose is dependent on what questions they need to answer, the context of the research environment, how much data they already have, and what resources are available.

Here are the common types of case study design:

Explanatory

An explanatory case study is an initial explanation of the how or why that is behind something. This design is commonly used when studying a real-life phenomenon or event. Once the organization understands the reasons behind a phenomenon, it can then make changes to enhance or eliminate the variables causing it. 

Here is an example: How is co-teaching implemented in elementary schools? The title for a case study of this subject could be “Case Study of the Implementation of Co-Teaching in Elementary Schools.”

Descriptive

An illustrative or descriptive case study helps researchers shed light on an unfamiliar object or subject after a period of time. The case study provides an in-depth review of the issue at hand and adds real-world examples in the area the researcher wants the audience to understand. 

The researcher makes no inferences or causal statements about the object or subject under review. This type of design is often used to understand cultural shifts.

Here is an example: How did people cope with the 2004 Indian Ocean Tsunami? This case study could be titled "A Case Study of the 2004 Indian Ocean Tsunami and its Effect on the Indonesian Population."

Exploratory

Exploratory research is also called a pilot case study. It is usually the first step within a larger research project, often relying on questionnaires and surveys . Researchers use exploratory research to help narrow down their focus, define parameters, draft a specific research question , and/or identify variables in a larger study. This research design usually covers a wider area than others, and focuses on the ‘what’ and ‘who’ of a topic.

Here is an example: How do nutrition and socialization in early childhood affect learning in children? The title of the exploratory study may be “Case Study of the Effects of Nutrition and Socialization on Learning in Early Childhood.”

An intrinsic case study is specifically designed to look at a unique and special phenomenon. At the start of the study, the researcher defines the phenomenon and the uniqueness that differentiates it from others. 

In this case, researchers do not attempt to generalize, compare, or challenge the existing assumptions. Instead, they explore the unique variables to enhance understanding. Here is an example: “Case Study of Volcanic Lightning.”

This design can also be identified as a cumulative case study. It uses information from past studies or observations of groups of people in certain settings as the foundation of the new study. Given that it takes multiple areas into account, it allows for greater generalization than a single case study. 

The researchers also get an in-depth look at a particular subject from different viewpoints.  Here is an example: “Case Study of how PTSD affected Vietnam and Gulf War Veterans Differently Due to Advances in Military Technology.”

Critical instance

A critical case study incorporates both explanatory and intrinsic study designs. It does not have predetermined purposes beyond an investigation of the said subject. It can be used for a deeper explanation of the cause-and-effect relationship. It can also be used to question a common assumption or myth. 

The findings can then be used further to generalize whether they would also apply in a different environment.  Here is an example: “What Effect Does Prolonged Use of Social Media Have on the Mind of American Youth?”

Instrumental

Instrumental research attempts to achieve goals beyond understanding the object at hand. Researchers explore a larger subject through different, separate studies and use the findings to understand its relationship to another subject. This type of design also provides insight into an issue or helps refine a theory. 

For example, you may want to determine if violent behavior in children predisposes them to crime later in life. The focus is on the relationship between children and violent behavior, and why certain children do become violent. Here is an example: “Violence Breeds Violence: Childhood Exposure and Participation in Adult Crime.”

Evaluation case study design is employed to research the effects of a program, policy, or intervention, and assess its effectiveness and impact on future decision-making. 

For example, you might want to see whether children learn times tables quicker through an educational game on their iPad versus a more teacher-led intervention. Here is an example: “An Investigation of the Impact of an iPad Multiplication Game for Primary School Children.” 

• When do you use case studies?

Case studies are ideal when you want to gain a contextual, concrete, or in-depth understanding of a particular subject. It helps you understand the characteristics, implications, and meanings of the subject.

They are also an excellent choice for those writing a thesis or dissertation, as they help keep the project focused on a particular area when resources or time may be too limited to cover a wider one. You may have to conduct several case studies to explore different aspects of the subject in question and understand the problem.

• What are the steps to follow when conducting a case study?

1. Select a case

Once you identify the problem at hand and come up with questions, identify the case you will focus on. The study can provide insights into the subject at hand, challenge existing assumptions, propose a course of action, and/or open up new areas for further research.

2. Create a theoretical framework

While you will be focusing on a specific detail, the case study design you choose should be linked to existing knowledge on the topic. This prevents it from becoming an isolated description and allows for enhancing the existing information. 

It may expand the current theory by bringing up new ideas or concepts, challenge established assumptions, or exemplify a theory by exploring how it answers the problem at hand. A theoretical framework starts with a literature review of the sources relevant to the topic in focus. This helps in identifying key concepts to guide analysis and interpretation.

3. Collect the data

Case studies are frequently supplemented with qualitative data such as observations, interviews, and a review of both primary and secondary sources such as official records, news articles, and photographs. There may also be quantitative data —this data assists in understanding the case thoroughly.

4. Analyze your case

The results of the research depend on the research design. Most case studies are structured with chapters or topic headings for easy explanation and presentation. Others may be written as narratives to allow researchers to explore various angles of the topic and analyze its meanings and implications.

In all areas, always give a detailed contextual understanding of the case and connect it to the existing theory and literature before discussing how it fits into your problem area.

• What are some case study examples?

What are the best approaches for introducing our product into the Kenyan market?

How does the change in marketing strategy aid in increasing the sales volumes of product Y?

How can teachers enhance student participation in classrooms?

How does poverty affect literacy levels in children?

Case study topics

Case study of product marketing strategies in the Kenyan market

Case study of the effects of a marketing strategy change on product Y sales volumes

Case study of X school teachers that encourage active student participation in the classroom

Case study of the effects of poverty on literacy levels in children

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• Case Study | Definition, Examples & Methods

Case Study | Definition, Examples & Methods

Published on 5 May 2022 by Shona McCombes . Revised on 30 January 2023.

A case study is a detailed study of a specific subject, such as a person, group, place, event, organisation, or phenomenon. Case studies are commonly used in social, educational, clinical, and business research.

A case study research design usually involves qualitative methods , but quantitative methods are sometimes also used. Case studies are good for describing , comparing, evaluating, and understanding different aspects of a research problem .

Table of contents

When to do a case study, step 1: select a case, step 2: build a theoretical framework, step 3: collect your data, step 4: describe and analyse the case.

A case study is an appropriate research design when you want to gain concrete, contextual, in-depth knowledge about a specific real-world subject. It allows you to explore the key characteristics, meanings, and implications of the case.

Case studies are often a good choice in a thesis or dissertation . They keep your project focused and manageable when you don’t have the time or resources to do large-scale research.

You might use just one complex case study where you explore a single subject in depth, or conduct multiple case studies to compare and illuminate different aspects of your research problem.

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Once you have developed your problem statement and research questions , you should be ready to choose the specific case that you want to focus on. A good case study should have the potential to:

• Provide new or unexpected insights into the subject
• Challenge or complicate existing assumptions and theories
• Propose practical courses of action to resolve a problem
• Open up new directions for future research

Unlike quantitative or experimental research, a strong case study does not require a random or representative sample. In fact, case studies often deliberately focus on unusual, neglected, or outlying cases which may shed new light on the research problem.

If you find yourself aiming to simultaneously investigate and solve an issue, consider conducting action research . As its name suggests, action research conducts research and takes action at the same time, and is highly iterative and flexible. 

However, you can also choose a more common or representative case to exemplify a particular category, experience, or phenomenon.

While case studies focus more on concrete details than general theories, they should usually have some connection with theory in the field. This way the case study is not just an isolated description, but is integrated into existing knowledge about the topic. It might aim to:

• Exemplify a theory by showing how it explains the case under investigation
• Expand on a theory by uncovering new concepts and ideas that need to be incorporated
• Challenge a theory by exploring an outlier case that doesn’t fit with established assumptions

To ensure that your analysis of the case has a solid academic grounding, you should conduct a literature review of sources related to the topic and develop a theoretical framework . This means identifying key concepts and theories to guide your analysis and interpretation.

There are many different research methods you can use to collect data on your subject. Case studies tend to focus on qualitative data using methods such as interviews, observations, and analysis of primary and secondary sources (e.g., newspaper articles, photographs, official records). Sometimes a case study will also collect quantitative data .

The aim is to gain as thorough an understanding as possible of the case and its context.

In writing up the case study, you need to bring together all the relevant aspects to give as complete a picture as possible of the subject.

How you report your findings depends on the type of research you are doing. Some case studies are structured like a standard scientific paper or thesis, with separate sections or chapters for the methods , results , and discussion .

Others are written in a more narrative style, aiming to explore the case from various angles and analyse its meanings and implications (for example, by using textual analysis or discourse analysis ).

In all cases, though, make sure to give contextual details about the case, connect it back to the literature and theory, and discuss how it fits into wider patterns or debates.

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• Roberta Heale 1 ,
• Alison Twycross 2
• 1 School of Nursing , Laurentian University , Sudbury , Ontario , Canada
• 2 School of Health and Social Care , London South Bank University , London , UK
• Correspondence to Dr Roberta Heale, School of Nursing, Laurentian University, Sudbury, ON P3E2C6, Canada; rheale{at}laurentian.ca

https://doi.org/10.1136/eb-2017-102845

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What is it?

Case study is a research methodology, typically seen in social and life sciences. There is no one definition of case study research. 1 However, very simply… ‘a case study can be defined as an intensive study about a person, a group of people or a unit, which is aimed to generalize over several units’. 1 A case study has also been described as an intensive, systematic investigation of a single individual, group, community or some other unit in which the researcher examines in-depth data relating to several variables. 2

Often there are several similar cases to consider such as educational or social service programmes that are delivered from a number of locations. Although similar, they are complex and have unique features. In these circumstances, the evaluation of several, similar cases will provide a better answer to a research question than if only one case is examined, hence the multiple-case study. Stake asserts that the cases are grouped and viewed as one entity, called the quintain . 6  ‘We study what is similar and different about the cases to understand the quintain better’. 6

The steps when using case study methodology are the same as for other types of research. 6 The first step is defining the single case or identifying a group of similar cases that can then be incorporated into a multiple-case study. A search to determine what is known about the case(s) is typically conducted. This may include a review of the literature, grey literature, media, reports and more, which serves to establish a basic understanding of the cases and informs the development of research questions. Data in case studies are often, but not exclusively, qualitative in nature. In multiple-case studies, analysis within cases and across cases is conducted. Themes arise from the analyses and assertions about the cases as a whole, or the quintain, emerge. 6

Benefits and limitations of case studies

If a researcher wants to study a specific phenomenon arising from a particular entity, then a single-case study is warranted and will allow for a in-depth understanding of the single phenomenon and, as discussed above, would involve collecting several different types of data. This is illustrated in example 1 below.

Using a multiple-case research study allows for a more in-depth understanding of the cases as a unit, through comparison of similarities and differences of the individual cases embedded within the quintain. Evidence arising from multiple-case studies is often stronger and more reliable than from single-case research. Multiple-case studies allow for more comprehensive exploration of research questions and theory development. 6

Despite the advantages of case studies, there are limitations. The sheer volume of data is difficult to organise and data analysis and integration strategies need to be carefully thought through. There is also sometimes a temptation to veer away from the research focus. 2 Reporting of findings from multiple-case research studies is also challenging at times, 1 particularly in relation to the word limits for some journal papers.

Examples of case studies

Example 1: nurses’ paediatric pain management practices.

One of the authors of this paper (AT) has used a case study approach to explore nurses’ paediatric pain management practices. This involved collecting several datasets:

Observational data to gain a picture about actual pain management practices.

Questionnaire data about nurses’ knowledge about paediatric pain management practices and how well they felt they managed pain in children.

Questionnaire data about how critical nurses perceived pain management tasks to be.

These datasets were analysed separately and then compared 7–9 and demonstrated that nurses’ level of theoretical did not impact on the quality of their pain management practices. 7 Nor did individual nurse’s perceptions of how critical a task was effect the likelihood of them carrying out this task in practice. 8 There was also a difference in self-reported and observed practices 9 ; actual (observed) practices did not confirm to best practice guidelines, whereas self-reported practices tended to.

Example 2: quality of care for complex patients at Nurse Practitioner-Led Clinics (NPLCs)

The other author of this paper (RH) has conducted a multiple-case study to determine the quality of care for patients with complex clinical presentations in NPLCs in Ontario, Canada. 10 Five NPLCs served as individual cases that, together, represented the quatrain. Three types of data were collected including:

Review of documentation related to the NPLC model (media, annual reports, research articles, grey literature and regulatory legislation).

Interviews with nurse practitioners (NPs) practising at the five NPLCs to determine their perceptions of the impact of the NPLC model on the quality of care provided to patients with multimorbidity.

Chart audits conducted at the five NPLCs to determine the extent to which evidence-based guidelines were followed for patients with diabetes and at least one other chronic condition.

The three sources of data collected from the five NPLCs were analysed and themes arose related to the quality of care for complex patients at NPLCs. The multiple-case study confirmed that nurse practitioners are the primary care providers at the NPLCs, and this positively impacts the quality of care for patients with multimorbidity. Healthcare policy, such as lack of an increase in salary for NPs for 10 years, has resulted in issues in recruitment and retention of NPs at NPLCs. This, along with insufficient resources in the communities where NPLCs are located and high patient vulnerability at NPLCs, have a negative impact on the quality of care. 10

These examples illustrate how collecting data about a single case or multiple cases helps us to better understand the phenomenon in question. Case study methodology serves to provide a framework for evaluation and analysis of complex issues. It shines a light on the holistic nature of nursing practice and offers a perspective that informs improved patient care.

• Gustafsson J
• Calanzaro M
• Sandelowski M

Competing interests None declared.

Provenance and peer review Commissioned; internally peer reviewed.

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• v.11(2); 2022

Defining case management success: a qualitative study of case manager perspectives from a large-scale health and social needs support program

Margae knox.

1 School of Public Health, University of California, Berkeley, Berkeley, California, USA

Emily E Esteban

2 Contra Costa Health Services, Martinez, California, USA

Elizabeth A Hernandez

Mark d fleming, nadia safaeinilli, amanda l brewster, associated data.

No data are available. Data are not publicly available to protect potentially sensitive information. For data inquiries, please contact the corresponding author.

Health systems are expanding efforts to address health and social risks, although the heterogeneity of early evidence indicates need for more nuanced exploration of how such programs work and how to holistically assess program success. This qualitative study aims to identify characteristics of success in a large-scale, health and social needs case management program from the perspective of interdisciplinary case managers.

Case management program for high-risk, complex patients run by an integrated, county-based public health system.

Participants

30 out of 70 case managers, purposively sampled to represent their interdisciplinary health and social work backgrounds. Interviews took place in March–November 2019.

Primary and secondary outcome measures

The analysis intended to identify characteristics of success working with patients.

Case managers described three characteristics of success working with patients: (1) establishing trust; (2) observing change in patients’ mindset or initiative and (3) promoting stability and independence. Cross-cutting these characteristics, case managers emphasised the importance of patients defining their own success, often demonstrated through individualised, incremental progress. Thus, moments of success commonly contrasted with external perceptions and operational or productivity metrics.

Conclusions

Themes emphasise the importance of compassion for complexity in patients’ lives, and success as a step-by-step process that is built over longitudinal relationships.

What is already known on this topic?

• Case management programs to support health and social needs have demonstrated promising yet mixed results. Underlying mechanisms and shared definitions of successful case management are underdeveloped.

What this study adds?

• Case managers emphasised building trust over time and individual, patient-defined objectives as key markers of success, a contrast to commonly used quantitative evaluation metrics.

How this study might affect research, practice or policy?

• Results suggest that lighter touch case management interventions face limitations without an established patient relationship. Results also support a need for alternative definitions of case management success including patient-centered measures such as trust in one’s case manager.

Introduction

Health system efforts to address both health and social needs are expanding. In the USA, some state Medicaid programmes are testing payments for non-medical services to address transportation, housing instability and food insecurity. Medicaid provides healthcare coverage for lower income individuals and families, jointly funded by federal and state governments. Similarly, social prescribing, or the linking of patients with social needs to community resources, is supported by the UK’s National Health Service and has also been piloted by Canada’s Alliance for Healthier Communities. 1

A growing evidence base suggests promising outcomes from healthcare interventions addressing social needs. In some contexts, case managers or navigators providing social needs assistance can improve health 2 and reduce costly hospital use. 3–5 Yet systematic reviews also report mixed results for measures of health and well-being, hospitalisation and emergency department use, and overall healthcare costs. 6–9 Notably, a randomised trial of the Camden Care Coalition programme for patients with frequent hospitalisations due to medically and socially complex needs 10 found no difference in 180-day readmission between patients assigned to a care transitions programme compared with usual hospital postdischarge care. In the care transition programme, patients received follow-up from a multidisciplinary team of nurses, social workers and community health workers. The team conducted home visits, scheduled and accompanied patients to follow-up outpatient visits, helped with managing medications, coached patients on self-care and connected patients with social services and behavioural healthcare. The usual care group received usual postdischarge care with limited follow-up. 11 This heterogeneity of early evidence indicates a need for more nuanced explorations of how social needs assistance programmes work, and how to holistically assess whether programmes are successful. 12 13

Social needs case management may lead to health and well-being improvements through multiple pathways involving both material and social support. 14 15 Improvements are often a long-term, non-linear process. 16 17 At the same time, quality measures specific to social needs assistance programmes currently remain largely undefined. Studies often analyse utilisation and cost outcomes but lack granularity on interim processes and markers of success.

In order to translate a complex and context-dependent intervention like social needs case management from one setting to another, these interim processes and outcomes need greater recognition. 18–20 Early efforts to refine complex care measures are underway and call out a need for person-centred and goal-concordant measures. 21 Further research on how frontline social needs case managers themselves define successes in their work could help leaders improve programme design and management and could also inform broader quality measure development efforts.

Our in-depth, qualitative study sought to understand how case managers defined success in their work with high-risk patients. Case managers were employed by CommunityConnect, a large-scale health and social needs care management programme that serves a mixed-age adult population with varying physical health, mental health and social needs. Each case manager’s workflow includes an individualised, regularly updated dashboard of operational metrics. It is unclear, however, whether or how these operational factors relate to patient success in a complex care programme. Thus, the case managers’ perspectives on defining success are critical for capturing how programmes work and identifying essential principles.

Study design and setting

In 2017, the Contra Costa County Health Services Department in California launched CommunityConnect, a case management programme to coordinate health, behavioural health and social services for County Medicaid patients with complex health and social conditions. The County Health Services Department serves approximately 15% (180 000) of Contra Costa’s nearly 1.2 million residents. CommunityConnect enrollees were selected based on a predictive model, which leveraged data from multiple county systems to identify individuals most likely to use hospital or emergency room services for preventable reasons. Enrollees are predominantly women (59%) and under age 40 (49%). Seventy-seven per cent of enrollees have more than one chronic condition, particularly hypertension (42%), mood disorders (40%) and chronic pain (35%). 22 Programme goals include improving beneficiary health and well-being through more efficient and effective use of resources.

Each case manager interviewed in this study worked full time with approximately 90 patients at a time. Case managers met patients in-person, ideally at least once a month for 1 year, although patients sometimes continue to receive ongoing support at the case manager’s discretion in cases of continued need. Overall, up to 6000 individuals at a time receive in-person case management services through CommunityConnect, with approximately 200–300 added and 200–300 graduated per month. At the time of the study, CommunityConnect employed approximately 70 case managers trained in various public health and social work disciplines (see table 1 , Interview Sample). Case managers and patients are matched based on an algorithm that prioritises mental health history, primary language and county region.

Interview sample

Although case managers bring unique experience from their respective discipline, all are expected to conduct similar case management services. Services included discussing any unmet social needs with patients, coordinating applicable resources and partnering with the patient and patient’s care team to improve physical and emotional health. The programme tracks hospital and emergency department utilisation as well as patient benefits such as food stamps, housing or transportation vouchers and continuous Medicaid coverage on an overall basis. Each case manager has access to an individualised dashboard that includes operational metrics such as new patients to contact, and frequency of patient contacts, timeliness for calling patients recently discharged from the hospital, whether patients have continuous Medicaid coverage, and completion of social risk screenings.

Study recruitment

Semistructured interviews were conducted with 30 field-based case managers as part of the programme’s evaluation and quality improvement process. Participants included four mental health clinical specialists, five substance abuse counsellors, six social workers, nine public health nurses, four housing support specialists and two community health worker specialists. Case managers were recruited by email and selected based on purposive sampling to reflect membership across disciplines and experience working with CommunityConnect for at least 1 year. Three case managers declined to participate. Interviews ended when data saturation was achieved. 23

Interview procedures

Interviews were conducted by five CommunityConnect evaluation staff members (including EEE), who received training and supervision from the evaluation director (EH), who also conducted interviews. The evaluation staff were bachelor and masters-level trained. The evaluation director was masters-level trained and held prior experience in healthcare quality and programme planning.

The evaluation team drafted the interview guide to ask about a variety of work processes and experiences with the goal of improving programme operations including staff and patient experiences. Specific questions analysed for this study were (1) how case managers define success with a patient and (2) examples where case managers considered work with patients a success.

Interviews took place in-person in private meeting rooms at case managers’ workplace from March 2019 – November 2019. Interviews lasted 60–90 min and only the interviewer and case manager were present. All interviewers were familiar with CommunityConnect yet did not have a prior relationship with case managers. Case managers did not receive compensation beyond their regular salary for participating in the study and were allowed to opt out of recruitment or end the interview early for any reason. All interviews were audio recorded, transcribed and entered into Nvivo V.12 for analysis.

Patient and public involvement

This project focused on case manager’s perspectives and thus did not directly involve patients. Rather, patients were involved through case manager recollections of experiences working with patients.

Data analysis

We used an integrated approach to develop an initial set of qualitative codes including deductive coding of programme processes and concepts, followed by inductive coding of how case managers defined success. All interviews were coded by two researchers experienced in qualitative research (EEE and MK). Themes were determined based on recurrence across interviews and illustrative examples and being described by more than one case manager type. The two researchers identified preliminary themes independently, then consulted with one another to achieve consensus on final themes. Themes and supporting quotes were then presented to the full author team to ensure collective agreement that key perspectives had been included. Preliminary results were also shared at a staff meeting attended by case managers and other staff as an opportunity for feedback on study findings. This manuscript addresses the Standards for Reporting Qualitative Research, 24 and the Consolidated Criteria for Reporting Qualitative Research checklist is provided as an appendix. 25

All case manager participants provided informed consent. Research procedures were approved by the Contra Costa Regional Medical Center and Health Centers Institutional Review Committee (Protocol 12-17-2018).

Case managers frequently and across multiple roles mentioned three characteristics of success when working with patients: (1) establishing trust; (2) fostering change in patients’ mindset or initiative and (3) promoting stability and independence. Across these characteristics, case managers expressed that success is patient-defined, with individualised and often incremental progress—a contrast with external perceptions of success and common operational or productivity metrics (see figure 1 ).

Illustration of key themes.

Success is establishing trust

Trusting relationships were the most widely noted characteristic of success. Trust was described as both a product of case managers’ consistent follow-up and helpfulness over time and a foundational step to enable progress on patient-centred goals. To build trust, case managers explained, patients must feel seen and heard, and understand the case managers’ desire to help: ‘Success is to know that she knows me very well…I look for her on the streets, and I’m waiting for her to call me back. Hopefully she knows that when she’s ready I will be there at least to provide that resource for her and so it’s that personal relationship that you build’ (Case manager 11, social worker). Case managers also highlighted the longitudinal relationship required to establish trust, distinguishing success as more than one-time information delivery or navigating bureaucratic processes to procure services.

Case managers also identified trust as foundational to provide better support for patients: ‘So they’re as honest with me as they can be. That way I have a clear understanding about realistically what I can do to help them coordinate their care or link them to services.’ (Case manager 2, mental health clinician specialist). Establishing trust was essential to improve communication with patients and produced an amplifying effect. That is, a case manager’s initial help and follow-up builds trust so that patients can be more open, and open communication helps the case manager know what specific services can be most useful. This positive feedback loop further cements trust and builds momentum for a longitudinal relationship.

Permission to have a home visit was mentioned as a valuable indicator of early success in building trust: ‘(Your home is) your sanctuary’, expressed one case manager (Case manager 29, public health nurse), acknowledging the vulnerability of opening one’s home to an outsider. For another case manager, regular home visits in the context of a trusting relationship made the case manager aware of and able to address a difficult situation: ‘Every time I was going to her home, I was noticing more and more gnats flying around… She said it’s because of the garbage…’ After establishing trust, the patient allowed the case manager access to the bedroom where the case manager uncovered numerous soiled diapers. The case manager arranged professional cleaning and sanitation through CommunityConnect, after which, ‘there was room for a dance floor in her bedroom. There was so much room, and the look on her face, it was almost as if her chest got proud, just in that day. She didn’t seem so burdened…So that’s a success’ (Case manager 4, substance abuse counsellor). Across multiple examples, case managers expressed trust as a critical element for effective patient partnerships.

However, the pathways to building trust are less clear cut. Quick wins through tangible support such as a transportation voucher to a medical appointment could help engage a patient initially. Yet case managers more frequently emphasised strategies based on relationships over time. Strategies included expressing empathy (putting yourself in the patient’s shoes), demonstrating respect (especially when the patient has experienced disrespect in other health system encounters), keeping appointments, following through on what you say you will do, calling to check in and ‘being there’. Overall, case managers expressed that trust lets patients know they are not alone and sets the stage for future success.

Success is fostering a change in patients’ mindset or initiative

Case managers described a change in patients’ mindset or initiative as evidence of further success. One case manager explained, ‘Really (success) could be a switch in mind state… If I can get someone to consider addressing an issue. Or just acknowledging an issue. That’s progress’ (Case manager 24, substance abuse counsellor). Another case manager spoke to the importance of mindset by stating, ‘what I try to do is not just change the surface of life’. This case manager elaborated, ‘You help (a patient) get their housing and they’re gonna lose it again, unless they change; something changes in their mindset, and then they see things differently.’ (Case manager 6, mental health clinician specialist). Some case managers suggested that the supportive resources they provide are only band-aid solutions if unaccompanied by a changed mindset to address root causes.

Case managers reported that shared goals and plans are essential, in contrast to solutions identified by case managers without patient involvement. ‘I can’t do everything for them’, expressed one case manager (Case manager 21, public health nurse), while others similarly acknowledged that imposing self-improvement goals or providing resources for which a patient may not be ready may be counterproductive. Rather, one case manager emphasised, ‘I think it’s really important to celebrate people’s ideas, their beliefs, their own goals and values’. (Case manager 4, substance abuse counsellor). As an example, the case manager applauded a patient’s ideas of getting a driver’s license and completing an education certificate. In summary, case managers viewed success as a two-way street where patient’s own ideas and motivation were essential for long-term impact.

Success is promoting stability and independence

Case managers also identified patients’ stability and independence as a characteristic of success. One case manager stated, ‘I define success as having them be more independent in their just manoeuvring the system…how they problem solve’ (Case manager 30, public health nurse). Relative to the other characteristics of success, stability and independence more closely built on resources and services coordinated or procured by the case manager. For example, CommunityConnect provides cell phones free-of-charge to patients who do not currently have a phone or continuous service, which has helped patients build a network beyond the case manager: ‘Once we get them that cell phone then they’re able to make a lot of connections … linking to services on their own. They actually become a lot more confident in themselves is what I’ve seen’. (Case manager 23, substance abuse counsellor). In another example, a case manager helped a patient experiencing complex health issues to reconcile and understand various medications. For this patient stability means, ‘when he does go into the emergency room, it’s needed. … even though he’s taking his medication like he’s supposed to… it’s just his health gets bad. So, yea I would say that one (is a success)’ (Case manager 8, social worker). Thus, stability represents maintained, improved well-being, supported by care coordination and resources, even while challenges may still be present.

As a step further, ‘Absolute success’, according to one case manager, ‘(is when a patient) drops off my caseload and I don’t hear from them, not because they’re not doing well but because they are doing well, because they are independent’ (Case manager 12, social worker). Patients may still need periodic help knowing who to contact but can follow through on their own. This independence may arise because patients have found personal support networks and other resources that allow them to rely less and less on the case manager. While not all patients reach this step of sustained independence and stability, it is an accomplishment programmatically and for case managers personally.

Success is patient-defined, built on individualised and incremental progress

Case managers widely recognised that success comes in different shapes and sizes, dependent on their patient’s situation. Irrespective of the primary concern, many identified the patient’s own judgement as the benchmark for success. One case manager explained, ‘I define success with my patients by they are telling me it was a success. It’s by their expression, it’s just not a success until they say it’s a success for them’ (Case manager 7, social worker). In a more specific example, a case manager highlighted checking in with a patient instead of assuming a change is successful: ‘It’s not just getting someone housed or getting someone income. Like the male who we’re working towards reconciliation with his parents… that’s a huge step but if he doesn’t feel good about it… then that’s not a success.’ The same case manager elaborated, ‘it’s really engaging with the knowing where the patient him or herself is at mentally, for me. Yeah. That’s a success’ (Case manager 18, homeless services specialist). This comment challenges the current paradigm where, for example, if a patient has a housing need and is matched to housing, then the case is a success. Rather, case managers viewed success as more than meeting a need but also reciprocal satisfaction from the patient.

Often, case managers valued individualised, even if seemingly small, achievements as successes: ‘Every person’s different you know. A success could be just getting up and brushing their teeth. Sometimes success is actually getting them out of the house or getting the care they need’ (Case manager 28, social worker). Another case manager echoed, ‘(Success) depends on where they’re at … it runs the gamut, you know, but they’re all successes’ (Case manager 10, public health nurse). CommunityConnect’s interdisciplinary focus was identified as an important facilitator for tailoring support to individualised client needs. In contrast with condition-specific case management settings, for example, a case manager with substance abuse training noted, ‘whether someone wants to address their substance use or not, they still have these other needs, and (with CommunityConnect) I can still provide assistance’ (Case manager 24).

However, the individualised and incremental successes are not well captured by common case management metrics. One case manager highlighted a tension between operational productivity metrics and patient success, noting, ‘I get it, that there has to be accountability. We’re out in the field, I mean people could really be doing just a whole lot of nothing… (Yet), for me I don’t find the success in the numbers. I don’t think people are a number. Oh, look I got a pamphlet for you, I’m dropping it off… I don’t think that that is what’s really going to make this programme successful’ (Case manager 8, social worker). One case manager mentioned change in healthcare utilisation as a marker of success, but more often, case managers offered stories of patient success that diverge from common programme measures. For example, one case manager observed, ‘The clear (successes) are nice: when you apply for Social Security and they get it that’s like a hurrah. And then there’s other times it’s just getting them to the dentist’ (Case manager 28, social worker). Another case manager elaborated, ‘It’s not always the big number—the how many people did I house this year. It’s the little stuff like the fact that this 58-year-old woman who believes she’s pregnant and has been living outside for years and years, a victim of domestic violence, has considered going inside. Like that is gigantic’ (Case manager 18, homeless services specialist). Overwhelmingly, case managers defined success through the interpersonal relationship with their patients within patients’ complex, daily life circumstances.

Case managers’ definitions of success focused on establishing trust, fostering patients change in mindset or initiative, and, for some patients, achieving independence and stability. Examples of success were commonly incremental and specific to an individual’s circumstances, contrasting with programmatic measures such as reduction in hospital or emergency department utilisation, benefits and other resources secured, or productivity expectations. Study themes heavily emphasise the interpersonal relationship that case managers have with patients and underscore the importance of patient-centred and patient-defined definitions of success over other outcome measures.

Our results complement prior work on clinic-based programmes for complex patients. For example, interdisciplinary staff in a qualitative study of an ambulatory intensive care centre also identified warm relationships between patients and staff as a marker of success. 26 In another study interviewing clinicians and leaders across 12 intensive outpatient programmes, three key facilitators of patient engagement emerged: (1) financial assistance and other resources to help meet basic needs, (2) working as a multi-disciplinary care team and (3) adequate time and resources to develop close relationships focused on patient goals. 27 Our results concur on the importance of a multi-disciplinary approach, establishing trusting relationships, and pursuing patient-centred goals. Our results diverge on the role of resources to meet basic needs. Case managers in our study indicated that while connections to social services benefits and other resources help initiate the case manager-patient relationship, lasting success involved longer-term relationships in which they supported patients in developing patients’ own goal setting skills and motivation.

An important takeaway from case managers’ definitions of success is the ‘how’ they go about their work, in contrast to the ‘what’ of particular care coordination activities. For example, case managers emphasise interpersonal approaches such as empathy and respect over specific processes and resource availability. Primary care clinicians, too, have expressed how standard HEDIS or CAHPS quality metrics fail to capture, and in some cases disincentivise, the intuitions in their work that are important for high quality care. 28 29 Complex care management programmes must also wrestle with this challenge of identifying standards without extinguishing underlying quality constructs.

Strengths and limitations

This study brings several strengths, including bringing to light the unique, unexplored perspective of case managers working on both health and social needs with patients facing diverse circumstances that contribute to high-risk of future hospital or emergency department utilisation. The fact that our study explores perspectives across an array of case manager disciplines is also a strength, however a limitation is that we are unable to distinguish how success differed by discipline based on smaller numbers of each discipline in this study sample. Other study limitations include generalisability to other settings, given that all case managers worked for a single large-scale social needs case management programme. Comments around productivity concerns or interdisciplinary perspectives on ways to support patients may be unique to the infrastructure or management of this organisation. In addition, at the time of the study, all case managers were able to meet with patients in-person; future studies may explore whether definitions of success change when interactions become virtual or telephonic as occurred amidst COVID-19 concerns.

This study is the first to our knowledge to inquire about holistic patient success from the perspective of case managers in the context of a social needs case management programme. The findings offer important implications for researchers as well as policy makers and managers who are designing complex case management programmes.

Our results identify patient-directed goals, stability and satisfaction, as aspects of social needs case management which are difficult to measure but nonetheless critical to fostering health and well-being. Case managers indicated these aspects are most likely to emerge through a longer-term connection with their patients. Thus, while resource-referral solutions may play an important role in addressing basic needs, 30 our findings suggest that weak patient–referrer rapport may be a limitation for such lighter touch interventions. The need for sustained rapport building is also one explanation why longer time horizons may be necessary to show outcome improvements in rigorous studies. 16

Relatedly, results point to trusting relationships as an under-recognised and understudied feature of social needs case management. Existing research finds that patients’ trust in their primary care physician is associated with greater self-reported medication adherence 31 along with health behaviours such as exercise and smoking cessation. 32 Similar quantitative results have not yet been illuminated in social needs case management contexts, yet the prominence of trusting relationships in this study as well as other sources 26 27 33 34 suggests that measures of trust should be used to complement currently emphasised outcomes such as inpatient and outpatient utilisation. Future research and programme evaluation will need to develop new trust measurement or modify existing trust measures for the social needs case management context. 31 35

In summary, study themes provide waypoints of how to conceptualise programme design, new staff training and potential measurement development for complex case management programmes like CommunityConnect. Despite the broad swath of social needs addressed, case managers coalesced on establishing a trusting relationship as a necessary foundation to appropriately identify needs and facilitate connections. Second, fostering patients’ own ideas, including a change their mindset or initiative, was important to fully make use of programme resources. Third, supporting new-found independence or stability was a gratifying, but not universally achieved marker of success. Commonly, case managers highlighted moments of success with mindfulness toward small victories, illuminating that success is non-linear with no certain path nor single end point. Themes emphasise the importance of bringing compassion for the complexity in patients’ lives and developing collaborative relationships one interaction at a time.

Acknowledgments

The authors would like to thank the CommunityConnect evaluation team for their support conducting and transcribing interviews and applying preliminary coding, especially Gabriella Quintana, Alison Stribling, Julia Surges and Camella Taylor.

Contributors: MK coded and analysed qualitative data, identified key themes and related discussion areas, and drafted and critically revised the manuscript. EEE conducted interviews, coded and analysed qualitative data, and drafted and critically revised the manuscript. EH developed the study instrument, conducted interviews, supervised data collection, contributed to the data interpretation and critically revised the manuscript. MDF contributed to the interpretation and critically revised the manuscript. NS contributed to the interpretation and critically revised the manuscript. ALB contributed to the design and interpretation and critically revised the manuscript. All authors approve of the final version to be published.

Funding: MK was supported by the Agency for Healthcare Research and Quality (AHRQ) under the Ruth L. Kirschstein National Research Service Award T32 (T32HS022241). MDF was supported by the Agency for Healthcare Research and Quality, grant # K01HS027648.

Disclaimer: Its contents are solely the responsibility of the authors and do not necessarily represent the official views of AHRQ. Funding had no role in the study’s design, conduct or reporting.

Competing interests: None declared.

Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

Provenance and peer review: Not commissioned; externally peer reviewed.

Data availability statement

Ethics statements, patient consent for publication.

Not applicable.

Ethics approval

This study involves human participants and was approved by Contra Costa Regional Medical Center and Health Centers Institutional Review Committee (Protocol 12-17-2018). Participants gave informed consent to participate in the study before taking part.

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We work with investigators and scholars to catalyze innovation and discovery. We provide support for transdisciplinary collaborations, opportunity identification, team formation and proposal development. Our team is committed to the success of faculty and student research initiatives and increasing the College’s research capacity and competitiveness.

Our research development team is committed to helping CASE researchers. We specialize in proposal development, identification of relevant funding sources, training, and linking researchers to resources.

Rita Teutonico Faculty Administrator; Associate Dean of Research; Associate Director of [...]   305-348-2719   [email protected]  AHC4 353

Juan J. Lopez Grant Administrator III   305-348-5789   [email protected]  AHC4 352

Marta D'Elia Grant Administrator II - Research Development Officer; Postdoctoral Associate   305-919-4104   [email protected]  MSB 250D

Maria Valeria Perez Guida Grand Administrator III   305-348-4219   [email protected]  AC1 303A

Brian A. Raue Professor; Associate Dean of Graduate Studies   305-348-3958   [email protected]  CASE 476

Proposal Development

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Large and Collaborative Proposals

Our team focuses on providing assistance in the development stages of large, interdisciplinary and collaborative proposals. From team formation to management, planning and coordination throughout the proposal development process, we work with principal investigators and teams of researchers to support the creation of competitive proposals.

Individual Researchers and Smaller Proposals

Although our efforts are focused on assisting with the development of collaborative and large proposals, our team is available to help and guide individual researchers and provide them with resources.

Our goal is to increase research proposal competitiveness and the size and breadth of the overall research portfolio. While we do not replace ORED’s pre-award functions, we ensure that proposals are in the best and most complete form possible before they are sent to and submitted through ORED.

Our office can help with:

Identify a diverse set of funding opportunities.

• Identification of funding opportunities : Conduct a customized search on behalf of the faculty and/or assist faculty with setting up their own InfoSpin account and profiles for targeted searchs. 
• Solicitation and guidelines interpretation  (Grantsmanship): Interpret sponsor funding policy, eligibility criteria and other elements necessary to complete the submission.

Conduct brainstorming session for new ideas and/or new cross-disciplinary teams.

• Research collaboration and partnership building : Organize meetings to discuss collaboration opportunities, connect faculty, advise on forming interdisciplinary teams, tap into our extensive network of researchers, government agencies and community organizations, and team coordination.

Assist with proposal development.

• Navigating the proposal submission process: Assist in completing the sponsor’s agency online submission portal (e.g. grants.gov, research.gov).
• Proposal planning and development : Organize and facilitate meetings, create timelines to meet ORED and funding agency deadlines, coordinate and track assignments, create outlines for the writing team, and assemble necessary documents.
• Editing and proofreading  of narrative. 
• Revision and resubmission of declined proposals , including interpreting reviewers' comments.
• Required documents coordination:  Ensure that all elements of the required documents comply with the funding agency’s policies (including Biosketch, Data Management Plan, and others).
• Broader impact or other specific section development : Work with faculty to design impactful programs to highlight and advance their strategic development, navigating K12 school relationships, and connecting researchers with existing educational programs.

Facilitate interactions with ORED pre-award team.

• Budget and budget justification development:  Provide guidance on how to use the spreadsheet, draft budget justification, advice on ORED budget policies and procedures.
• ePRAF. Complete ePRAF questionnaire and ePRAF routing .

While we have designated each RD officer a primary school and/or institute responsibility based on their background, the CASE RD team supports all CASE researchers. We work jointly on most proposals and will assign team members to each proposal based on workload balance and upcoming deadlines. Please contact us for assistance at [email protected]  or via the  CASE Proposal Development Contact Form where you can indicate the type of assistance needed.

• Rita Teutonico, PhD , leads the Research Development Office and directs all areas of expertise provided by the office.
• Brian A. Raue, PhD , is the interim Associate Dean of Research.
• Marta D'Elia, PhD , primarily assists research teams from the School of Environment, Arts and Society (Biscayne Bay Campus) and the Institute of Environment.
• Juan J. Lopez primarily assists research faculty from the School of Integrated Science and Humanities and proposals to private foundations.
• M. Valeria Perez, MSc, MPA , primarily assist research faculty and teams from the School of Education and Human Development and the STEM Transformation Institute. 

Ready to transform your big idea into a reality? Our CASE Proposal Development Contact Form has been designed with the needs of investigators in mind. Once you have completed and submitted a contact form, one of our CASE Research Development team members will be assigned to work with you directly in the development of your proposal.

In order for our team to best assist you, please be sure to contact us at least two months prior to the proposal submission deadline.  Priority will be given to researchers who contact the CASE Research Development Office with information about solicitations/proposals of interest in a timely manner.

*All proposals to external sponsors for projects that will involve University faculty and/or staff must be sent to the FIU Office of Research and Economic Development at least 8 business days (if proposal contains  subawards ) or 5 business days (if proposal does not contain subawards ) prior to sponsor submission deadline for review, approval and submission .

CASE Proposal Development Contact Form

Research Resources

The FIU   Office of Research & Economic Development   lists various resources for finding funding sources:

• Federal grant opportunities   (feed is updated every Monday)
• Funding for students  and   resources for early-career faculty
• Internal funding opportunities
• Search tools

Explore information about university incentives for researchers who are interested in applying for external research funding:

• High Value   Faculty Awards and Fellowships
• Incentives for Researchers

In limited submission programs, the sponsor limits the number of applications that an institution may submit, leading to internal competitions within the university and the college.

• University Limited Submissions Competitions Our Team monitors the ORED website for posted internal competitions and sends announcements to college-wide faculty and researcher listservs when new opportunities are posted.
• CASE Limited Submissions Competitions In some cases, more than one application for a program may be submitted per institution, but there are limits on the number of applications that can be submitted per college within the institution. Our team will monitor the FIU Office of Research and Economic Development’s website daily for opportunities that require a college-level limited submission competition. Upon announcement of a Limited Submission competition, faculty interested in submitting a proposal are required to complete an online Notice of Intent (NOI).

Information about the university (demographics, facilities, university statics, etc.) is often requested for proposal submission. These are some tools to obtain this information.

• Institutional Data and Facilities
• Office of Analysis and Information Management (AIM)- University Statistics
• Student Demographics Report Tool
• The FIU Office of Research and Economic Development (ORED) offerers several   online resources for grant writing  and has an   External Grant Review Service  open to PI-eligible faculty members.
• The RDOffice repository of proposals 
• Proposal Writer's Guide  from the University of Michigan
• Proposal Writing Guide with Checklist & Examples
• Resubmitting a rejected Proposal by John Trango

Interested in applying for collaborative and interdisciplinary funding opportunities? Contact our team, we can help connect you with fellow investigators and assist with team management. 

• FIU College of Arts, Sciences & Education   Directory. Filter by unit and find researchers.
• Collaborations across colleges and departments are encouraged.   Contact us   for help.

Explore resources and more information about team formation and management:

• Building and managing a research team
• Advice for running a successful research team

The Fiscal Year 2023 Graduate Student Salary Rates are the following:

• Biology: $30,625 
• Biochemistry: $29,630
• Chemistry: $29,000
• Earth and Environment: $27,550
• Physics: $27,550
• Psychology (except Cog Neuro): $25,240
• Cog Neuro: $27,550
• Math: $27,550
• Teaching and Learning: $25,550
• Educational Policy Studies: $25,550

 PIs may petition for "extra hours" for their research students with a maximum allowed set at $32,000 for all of CASE. 

• Review ORED’s Proposal Preparation FAQs   for information concerning university fringe rates, F&A rates, cost-sharing and other budget-related inquiries.
• NSF Proposal Budget Reviews
• NSF Proposal and Award Policies and Procedures, 2021
• Collaborators and Other Affiliations Template
• Current and Pending Support
• Proposal and Award Policies and Procedures (PAPPG 23-1)
• Data Management Plan Guidelines
• Postdoctoral Mentoring Plan support
• Dissemination and Sharing of Research Results Policies
• Required Forms Checklist
• Budget Justification Template

Electronic Code of Federal Regulations

• Department of Education Institute for Education Sciences (IES)
• Department of Energy Office of Science (DoE OS)
• National Science Foundation (NSF)
• Environmental Protection Agency (EPA)
• USASpending (includes USDA, DoD, EPA, FDA, HHS, NASA, NSF, VA)
• Institute of Museum and Library Services (IMLS)
• National Endowment for the Humanities (NEH)

Your research has the opportunity to benefit society. In recent years, funding agencies have put greater emphasis on broader impacts and our team has the expertise to help you develop your broader impacts plan. Contact us at  [email protected]  to simply edit your proposal’s Broader Impacts section or to assist you in creating a powerful program to reach new audiences.

NSF Information on Broader Impacts 

Training & Events

We offer workshops for faculty, staff, postdoctoral scholars and graduate students to share knowledge and help cultivate skills that can lead to the development of competitive proposals.

Upcoming Events

Training and event dates will be posted here.

In addition, be sure to take advantage of the   ADVANCE Faculty Mentor Program   and check the   Office of Research and Economic Development events calendar   regularly for seminar and training opportunities.

Research Development Team College of Arts, Sciences & Education 11200 SW 8th Street Miami, FL 33199

Academic Health Center 4, Suite 350

[email protected]

Consortium for Advanced Science and Engineering

(uchicago case), the university of chicago consortium for advanced science and engineering (uchicago case) aims to broaden the intellectual scope of research activities at uchicago and affiliated institutions., proposals in 2023, affiliated institutions.

Apply to CASE

CASE Membership Types and Associated Privileges

CASE at-Large privileges include access to UC facilities and the library system, principal investigator or co-investigator status on grant applications at the University (where applicable), and UC research resources such as the Research Computing Center (RCC).

CASE members also benefit from UC system access including, but not limited to, mail forwarding, VPN, and Box.

CASE Affiliates receive additional privileges within the affiliated Unit, which include co-mentoring/co-supervising UC students and postdocs.

Please carefully review each category below to determine the appropriate CASE membership type prior to submitting an application.

Membership Descriptions

Your title goes here, staff member or postdoc at-large.

UChicago CASE Staff or Postdoc positions are for those whose primary appointments are at the home institution of their supervising CASE scientist/scholar, but who are involved in projects supported by grants obtained through the University. Staff/Postdocs will not have PI status, and UChicago CASE membership is linked to the status of the sponsoring PI.

Requirements:

• An application for UChicago CASE membership must be completed and submitted in full. Please note that UChicago CASE Staff- or Postdoc-at-Large status is restricted to affiliation with a specific UChicago CASE (Senior) Scientist/Scholar group or for staff situated with a specific UChicago research center or institute (e.g., Globus, EPIC).
• Information provided should include a support letter from the UChicago CASE (Senior) Scientist/Scholar group (or specific UChicago research center or institute), a current CV/biosketch, information about the research project being supported, and information about the home institution. Applicants also must follow any internal joint appointment approval process established at the home institution for potential UChicago CASE membership.
• Internal joint appointment approval must be sent directly from the home institution to the Office of Research.
• To be accepted into UChicago CASE, applicants must be approved by CASE and the home institution.

(Senior) Scientist/Scholar at-Large

UChicago CASE (Senior) Scientists/Scholars-at-Large will be the default appointment for scientists or scholars without existing ties with a specific unit.

• An application for UChicago CASE membership must be completed and submitted in full.
• Information provided should include the applicant’s rationale for seeking membership, a description of the proposed research or scholarly activities to be undertaken, a list of existing or possible faculty collaborators (if applicable), a current CV/biosketch, and a memo of support from the applicant’s cognizant supervisor of the home institution. Applicants also must follow any internal joint appointment approval process established at the home institution for potential UChicago CASE membership.

(Senior) Scientist/Scholar Affiliated with a Unit

UChicago CASE (Senior) Scientist/Scholar Affiliated with a Unit have existing collaborations within a specific academic unit and require the additional privilege of co-mentoring/co-supervising UChicago students and postdocs.

• Information provided should include the applicant’s rationale for seeking membership, a description of the proposed research or scholarly activities to be undertaken, the University unit where collaborations currently exist or will be established, a list of existing or possible faculty collaborators, a current CV/biosketch, and a memo of support from the applicant’s cognizant supervisor of the home institution. Applicants also must follow any internal joint appointment approval process established at the home institution for potential UChicago CASE membership.
• PME Affiliates: Separate application materials are required for Division Affiliation, GRC, and CASE. Please ensure that you have submitted all necessary materials to each office as appropriate.
• The Division/School within which the academic unit is situated determines the criteria and process for affiliation and may differ for different Divisions/Schools. Following the faculty review process with Dean’s concurrence, affiliation confirmation will be submitted to UChicago CASE directly by the Unit.
• To be accepted into UChicago CASE, applicants must be approved by the home institution, Affiliating UChicago School/Division, CASE, and Provost Offices.

Membership Privileges

• Access to UChicago facilities and library  
• Ability to charge time and grants without a subcontract  
• Access to mail forwarding, VPN, Wireless Networking, Wireless Networking Secure, Web Proxy, and Box  
• Serve as a PI or co-investigator on grant applications at the University 
• Purchase equipment via the University for use on University-administered grants 
• Hire and supervise staff at the University
• Serve as a PI or co-investigator on grant applications at the University  
• Purchase equipment via the University for use on University-administered grants  
• Hire and supervise staff at the University  
• Co-supervise and co-mentor UChicago students and postdocs  

Note: Affiliated with a Unit appointments require review and  approvals from the UChicago School/Division, CASE, and Provost Offices.

Note: Please ensure that you click on the correct position for the membership type to which you are applying. New users to UChicago Workday will be required to create an account in order to Start an Application.

For assistance in applying to UChicago CASE , please contact:

Research Development Support (RDS) Beth Ziolkowski     [email protected]

For Divisional assistance with CASE Affiliated with a Unit appointments, please contact:  

Physical Sciences Division (PSD)   Carly Bloss Associate Director of Academic Affairs 773-702-2630   [email protected]

Biological Sciences Division (BSD)   Connie Lee Associate Dean for Basic Science   (773) 834-4790   [email protected]  

Pritzker School of Molecular Engineering (PME)   LaKesha Lloyd, EA to the Dean [email protected]

GRC Participants: Visit GRC online or contact Lisa Vonesh at [email protected]

Onboarding Process

CNet ID assignment and UChicago systems access, required for proposal submission, can only be obtained through onboarding (post-approval).

1. Secure your UChicago systems access

HR: Workday and System Credentials Beth Ziolkowski Schedule an Appointment [email protected]

Please refer to your approval memo for more information on UChicago CASE onboarding.

Regenstein Library (Identity & Privileges Office): UChicago Campus Card & Library Services (773) 702-3344 [email protected]

Note: UChicago CASE privileges, including Campus Card and Library Services, require onboarding to set up system credentials.

2. Opt-in to award services supporting research proposals and/or funding

At-Large Anna Jackson (773) 834-2601 [email protected]

PME Affiliate LaKesha Lloyd & Lisa Vonesh [email protected] & [email protected]

PSD Affiliate Carly Bloss (773) 702-2630 [email protected]

BSD Affiliate Connie Lee (773) 834-4790 [email protected]

At-Large and PME Affiliate Gloria Mazzorana (773) 702-2398 [email protected]

BSD Affliate Connie Lee (773) 834-4790 [email protected]

Renew your membership

Failure to renew your appointment could result in loss of UChicago system privileges and/or federal research funding. Please refer to the renewal criteria to ensure you complete all steps for re-appointment. An approval memo with updated terms of renewal cannot be sent until all steps are complete.

To check your UChicago CASE membership renewal information, you may do so by logging into Workday @ UChicago . Here, you can view your UChicago profile which includes your contingent worker title (CASE membership type) as well as your contract end date (CASE membership term end) under “Job Details.” Please note that you must have a current, claimed UChicago  CNet ID  in order to view your Workday @ UChicago profile. If you have any questions on your UChicago CASE renewal status or term, please contact  [email protected] .

Renewal Criteria

• Renewal documents from your home institution, including an updated CV and supervisory approval; contact director or supervisor to initiate renewal, and send documentation to  [email protected]    
• Evidence of research activity such as submitted proposals and publications, provided via the Renewal Survey link on this page  

CASE Senior Scientist/Scientist or Scholar Affiliated with a Unit  

• All materials required for at-Large appointments (above)  
• Updated Letter of Support submitted to UChicago CASE by Affiliated Unit/Division

Review Process

• Request will be reviewed for approval after all materials are received by UChicago  

CASE Senior Scientist/Scholar Affiliated with a Unit

• Request will be reviewed for approval after all materials are received and Letter of Support from Faculty Mentor is approved  

Department of Defense Research Visit: Dr. Bindu Nair

Dr. Bindu Nair, DoD Director of Basic Research, visited the University of Chicago campus on September 29th to discuss…

PI Spotlight: Andrzej Joachimiak

Andrzej’s current research focuses on proteins and protein-nucleic acid interactions and includes enzymes, transcription factors and molecular chaperones.

PI Spotlight: Kate Keahey

When any successful project attracts a large community, there will be growing pains. Since its launch in 2015, the experimental cloud computing testbed Chameleon has realized its vision of becoming a shared scientific instrument for computer science research and education.

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• Research Roundtable: ClinicalTrials.gov FAQ — Results Reporting (Part 1)

Research Roundtable: ClinicalTrials.gov FAQ — Results Reporting (Part 1)

Published April 10, 2024

In the first part of a two-part series, “Research Roundtable” highlights elements of the “Results Reporting” FAQ section from ClinicalTrials.gov.

ClinicalTrials.gov  is a publicly available registry and results database of federally and privately supported clinical trials conducted in the United States and internationally. It has an extensive  FAQ section  ranging from general to investigation-specific. Many of these questions frequently arise at the University at Buffalo, primarily regarding either study registration or results posting. This edition of “Research Roundtable” is part one of a two-part series that highlights a selected FAQ, “Results Reporting.” 

Which types of studies are required to have results reported?

1. Applicable Clinical Trials (ACT) per Food and Drug Administration Amendments Act of 2007 (FDAAA), including:

• Trials of drug/biological products: Controlled, clinical investigations of a product subject to FDA regulations
• Trials of devices: Prospective controlled trials with health outcomes comparing a device against a control

Note that an ACT requirement must also meet one of the following:

• Trial has one site in the U.S.
• Trial is conducted under FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE)
• Trial involves a drug, biologic, or device that is manufactured in the U.S. and is exported for research

Excluded from this requirement per FDAAA are:

• Phase 1 drug trials
• Small clinical trials to determine the feasibility of a device
• Trials that do not include drugs, biologics, or devices (e.g., behavioral interventions)
• Non-interventional (observational) clinical research

2. All NIH-Funded Clinical Trials including studies with human subjects prospectively assigned to one or more interventions to evaluate the effects of interventions on health-related biomedical or behavioral outcomes.

Excluded from this requirement per NIH are studies intended solely to refine measures and studies that involve secondary research with biological specimens or health information.

When are results required to be entered into the study record?

The timeline for the  FDAAA  and the  NIH Policy  for submitting results information is no later than one year after the trial’s Primary Completion Date , which is the date that the final subject was examined, or received an intervention, for the purposes of final collection of data for the primary outcome .  

Is there guidance for entering study results?

Step-by-step instructions for submitting Results information into the ClinicalTrials.gov Protocol Registration and Results System (PRS) is provided in PRS Guided Tutorials .

Are there consequences for not submitting results?

FDA noncompliance with ClinicalTrials.gov registration and results reporting may result in fines, currently more than $14,000 per study/per day, for PIs and their institutions. Pre-notices may be issued for potential violations. For an NIH-funded study for which a grantee is the responsible party, failure to submit required results information could result in NIH not releasing remaining funding for a grant or funding for a future grant.

Can the timeline for entering results be extended?

A request can be made to delay the submission of results information by submitting a “good cause extension” via the PRS prior to the date that results information would be due.

What happens to the study record if the study is prematurely terminated/withdrawn?

Records that have a National Clinical Trial (NCT) number cannot be deleted. If no participants were ever enrolled in the trial, the “Overall Recruitment Status” can be set to “Withdrawn” and no results information will need to be submitted. ACTs and NIH-funded trials that terminate prematurely but have enrolled participants and collected data must report results on ClinicalTrials.gov. 

When does my obligation to update clinical trial information end?

For ACTs, NIH-funded trials, and voluntary trial submissions that are required to be registered, the responsible party's obligation to submit updates ends when all required clinical trial results information has been submitted and the responsible party has made all corrections and/or addressed all concerns in response to any notice received from PRS.

How can I get ClinicalTrials.gov help at UB?

For UB assistance with ClinicalTrials.gov registration and reporting requirements, contact the UB ClinicalTrials.gov team ( [email protected] ) or ClinicalTrials.gov PRS Administrators Lynn Jagodzinski ([email protected]), CTSI Clinical Research Regulatory Administrator, and Urmo “Mo” Jaanimägi ([email protected]), CTSI Quality Assurance Specialist.

Watch for part two of “ClinicalTrials.gov FAQ — Results Reporting” in an upcoming edition of “Research Roundtable.”

“Research Roundtable” is a section in the University at Buffalo Clinical and Translational Science Institute (CTSI)   Translational Spotlight  newsletter. Add your email to the newsletter mailing list   here .

UB partners with Roswell / U of Rochester for Empire Discovery Institute (EDI)

The new institute will streamline efforts to turn groundbreaking drug research into viable treatments and medicines, bringing new companies and new jobs.

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• CDER Conversations

CDER Conversation: Model Informed Drug Development

Talking with Raj Madabushi, Ph.D., Team Leader, Guidance and Policy Team, Office of Translational Sciences, Office of Clinical Pharmacology, CDER.

Model-informed drug development (MIDD) is an approach that involves developing and applying exposure-based, biological and statistical models derived from preclinical and clinical data sources to inform drug development and decision-making. It aims to integrate information from diverse data sources to help decrease uncertainty and lower failure rates, and to develop information that cannot or would not be generated experimentally 1 . Integrating MIDD into more drug applications and advancing its use are some of FDA’s goals under the Prescription Drug User Fee Amendments of 2017 (PDUFA VI).

Raj Madabushi, Ph.D., Team Leader, Guidance and Policy Team, Office of Translational Sciences, Office of Clinical Pharmacology, CDER, discusses the current status and promise of this approach.

What are the key elements of Model Informed Drug Development (MIDD)?

MIDD is based on three elements:

• Leveraging a thorough understanding of the drug, a disease, and how a drug affects the human body , as well as how the body responds to the drug.
• Quantifying information by developing mathematical models based on full use of all available data, from sources such as in vitro (e.g., outside the body), preclinical and clinical studies.
• Applying this knowledge to address issues pertaining to drug development or clinical use . MIDD has been applied to predict clinical outcomes, inform clinical trial designs, support evidence of effectiveness, optimize dosing, predict product safety, and evaluate potential adverse events. MIDD approaches routinely provide a starting point for pediatric drug development, based on solid understanding of developmental physiology and disease pathology. In some disease areas, dosing in children is based on MIDD approaches.

What activities are planned to support the PDUFA VI goal of advancing the use of MIDD?

FDA is planning multiple activities to advance the use of MIDD under PDUFA VI. These include four workshops focusing on best practices and methodological limitations, a pilot program , updated guidance, and new standard operating procedures for conducting specific analyses.

The workshops will offer a forum for discussions among experts, with the goal of achieving consensus and providing clarity on areas that are already well advanced, and areas needing more effort. These discussions can also ensure that MIDD is fully understood by everyone, including decision-makers. Workshop topics include (1) physiologically-based pharmacokinetic modeling; (2) design analysis and inferences from dose-exposure-response studies; (3) disease progression model development, including natural history and trial simulation; and (4) immunogenicity and correlates of protection for evaluating biological products, including vaccines and blood products. 2

Under the pilot program, an internal FDA group will review programs with limited clinical data, and where non-traditional sources of evidentiary support may be helpful. The pilot program aims to advance the use of MIDD as part of the regulatory pathway for drugs, helping both FDA and sponsors to work through issues around developing models, establishing their credibility, and determining how they can be used to address regulatory or drug development issues.

FDA plans to publish a draft guidance on MIDD or revise relevant existing guidances. In addition, the agency will develop or revise relevant policies and procedures, review templates, and conduct training that will help sponsors and reviewers understand how to use MIDD consistently as part of the regulatory process.

How can MIDD potentially streamline and accelerate drug development?

MIDD can streamline and accelerate the development of new medical products by helping to design better future trials. In some instances, MIDD can reduce the need for additional clinical trials, require fewer patients for studies, or increase the probability of success by aiding in the selection of the right dosing, duration, and patient population. These advantages enable more informed decision-making, and reduce uncertainty when moving between phases of development, giving sponsors confidence to move more quickly to the next phase.

MIDD has been applied in many areas. The approach has helped sponsors identify target concentrations and therapeutic windows; examine drug-drug interactions; optimize doses, particularly in children; ensure the safety of specific populations; and design better trials. As a result, some companies have been able to perform smaller or shorter clinical studies, and carry out fewer postmarketing studies. 3

How do MIDD approaches bring value to regulatory decision-making and therapeutic use?

MIDD is unique in that it can provide insights about the benefits and risks of new therapies beyond the primary intent of clinical trials.

Clinical trials are carried out in a sample of patients with a disease, and are aimed mainly at answering one or several questions, such as whether the primary outcome measure differs significantly between or among treatment groups. But other questions may arise during regulatory review and once a new treatment is approved. For example:

• Can the dosing be optimized for the general population or high-risk subpopulations?
• Can we provide dosing for some unstudied subpopulations of interest?
• Are there risks when other medications are co-administered, and if so, how can these be mitigated?

MIDD can answer these and other questions by providing information to bridge efficacy and safety for certain unstudied patient subpopulations or use scenarios. This rational approach makes the most efficient use of available information to inform next steps or, in some cases, reduce or eliminate the need for additional trials.

What are the challenges in applying MIDD approaches to drug development and regulatory decision-making?

The limitations of MIDD are the same as those for any prediction approach – models are only as good as the data on which they are built. Models cannot always substitute for a basic level of required information. Also, the need for acceptance of MIDD is a major challenge. At present, MIDD is widely accepted in some therapeutic areas but not in others. Another challenge is that it is not yet applied consistently to critical drug development decisions and in regulatory decisions. These challenges underscore the need for best practices for determining when a model is deemed acceptable for application. MIDD best practices would also help clarify regulatory expectations. Today, extensive information is available to help make decisions. However, our infrastructure for warehousing the data and knowledge lags behind, which limits our ability to translate MIDD approaches to address drug development issues.

What is the future landscape of MIDD?

Industry has been proactively using MIDD approaches to supplement internal decisions as part of drug development. Moreover, the activities outlined under PDUFA VI goals will determine how MIDD approaches are applied to regulatory decision-making. There have been exciting advances in new approaches and methods of analysis, allowing for greater use of the totality of evidence than in the past. We are seeing advances in understanding the physiological basis of disease and in systems pharmacology. These advances are helping us anticipate who might be at risk for certain diseases or drug safety events. Ongoing innovation will offer more chances to enhance the value offered by MIDD in drug development.

Global initiatives are also underway. The European Medicines Agency is actively developing best practices, and similar efforts are ongoing at the Japan Pharmaceuticals and Medical Devices Agency. There is also interest in a consolidated approach by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

These and other future efforts bode well for MIDD approaches to deliver on their promise.

For more information: Read about the Model-Informed Drug Development Pilot Program .

The case for compliance as a competitive advantage for banks

Consider this short tale of two banks: Acme Bank’s top-notch compliance function kept the bank within its risk appetite, but the bank did not perform well. Its strategy team blamed compliance for slow growth, weak market share, and failed digital initiatives. At Apex Bank, the strategy team bypassed compliance to release new products quickly, expand into new customer segments, and ramp up acquisitions, all while keeping costs low. Soon, though, its main regulator brought a significant enforcement action. The stock price fell, key employees quit, the bank had to exit several important businesses, and compliance costs skyrocketed.

While these descriptions are caricatures, they’re not far from reality. Strategy and compliance often operate as antagonists or as ships passing in the night. This is a missed opportunity. Done well, communication and collaboration between the two parties can create competitive advantage. The stakes are particularly high now: technology offers promise, but new risks are rising on uncertain economic and geopolitical landscapes.

This article explains the benefits available when compliance and strategy leaders work together, the quick wins that are possible, and the structural solutions that can sustain and scale the change. In this article, we use the word “strategy” as a metonym for the broader set of decision makers (not just the strategy organization) who influence and shape banks’ strategic direction; these include business unit leaders, leaders in marketing and sales organizations, and product managers.

Finding competitive advantage

Banks’ compliance functions have typically focused on defense: preventing violations of policy, rules, regulation, and laws. The more complicated the regulatory, business, and technological environment, the more complex the defense.

But in complex environments, collaboration with the business  can deliver greater strategic value . In our experience, five objectives that define strategic posture  are ripe for collaboration: differentiating client experience, investing in fast-evolving areas, securing resilience against geopolitical disruptions, improving productivity, and acquiring programmatically. In each, when compliance and business stakeholders responsible for strategic decisions work side by side, institutions benefit by protecting against the downside, capturing more of the upside, or both (exhibit) .

In working with banks around the world, we have seen examples of compliance and strategy collaborating on these five objectives, with varying degrees of success. Here we describe how the successful collaborations were achieved for each objective.

Differentiated client experience

In the increasingly digital world, customer experience is king , and products and services are scrutinized in the court of public opinion—online ratings and social media. Already in 2018, of the 50 largest global banks, three out of four were publicly pledging to initiate some form of customer-experience transformation . We have seen banks’ customer-experience transformations boost the lifetime profitability of satisfied customers—those willing to recommend the bank to friends—to levels five to eight times those of customers with a negative perception.

Banks need processes that deliver a good customer experience in the moment, treat customers fairly, protect against fraud, and comply with laws and other regulations. Poorly designed compliance processes can compromise the experience, but insufficient checks can open the door to fraud or other abuses. Deep collaboration by compliance and business teams can capture opportunities as well as protect the downside.

Poorly designed compliance processes can compromise the experience, but insufficient checks can open the door to fraud or other abuses. Deep collaboration by compliance and business teams can capture opportunities as well as protect the downside.

For example, in retail banking and payments, some consumers have negative experiences with identity verification; it can be confusing and take a long time. Frustrated consumers may even walk away from their bank. Strategy teams with expertise in identifying customer needs, meeting those needs, and differentiating value propositions by bringing together viewpoints from across the organization can work with compliance teams to identify the most critical needs and embed compliance requirements seamlessly into customer journeys.

In institutional banking, some customers experience similar frustrations from the intense and sometimes overlapping queries for information aimed at meeting the complex know-your-customer (KYC) requirements straddling jurisdictions. Certain KYC queries may add operational cost and could even deter large multinational clients from starting new banking relationships. Closer collaboration between compliance and strategy teams helps banks simplify the process in a client-centric and risk-informed way. Our research has found  10 to 30 percent improvement in customer satisfaction scores and 20 to 40 percent reductions of administrative touchpoints.

Compliance and strategy teams can also work together on continual improvement. Customer complaints can indicate compliance issues—for example, problematic sales practices—but also opportunities to improve customer experience. Thus, input on customer experience can serve as an early warning about possible compliance issues.

How to start

Compliance and business operations can together initiate a review of priority client-facing processes. The effort may identify opportunities for improving user experience through simplification or rationalization of controls—for example, by removing redundant or overlapping controls.

Banks that aspire to offer a standout client experience typically form cross-functional teams focused on rapid, agile execution. Practically, this would involve including compliance experts in the core of the agile approach and team configuration from the start. For processes related to customer onboarding, teams can include experts in compliance, technology, operations, strategy, and other functions. This equips the team to incorporate guidance on compliance requirements in the most client-friendly way.

One North American institution created a task force of senior banking executives, including the chief compliance officer, to design a smooth customer onboarding process across its capital markets businesses. The team first established clarity around regulatory requirements and then reengineered customer journeys and built a consistent experience across regions. The resulting process minimized requests for client information and decreased the risk of inconsistencies and conflicts in client data.

Investment in fast-evolving areas

Growth into adjacent or secondary industries offers financial services institutions strong opportunity, yet some of the most alluring domains are fraught with uncertainty related to compliance. 1 Our recent research finds that in financial services, 35 percent of growth comes from secondary industries or expansion into new ones. Companies that grow into adjacent industries generated, on average, an extra 1.5 percentage points per year of shareholder returns above their industry peers. https://www.mckinsey.com/industries/financial-services/our-insights/managing-a-customer-experience-transformation-in-banking This is especially true of areas in which some combination of technology, products and services, business dynamics, and customer expectations are evolving quicky. Strategists weigh the opportunity from potential investments against costs of competition or regulation. Compliance can shape ideas for coping with the regulatory uncertainty and suggest implications for various investment options.

New business opportunities linked to data and analytics exemplify an area that shows promise but presents new and sometimes uncertain compliance expectations. Some institutions are considering investing in or partnering with data and analytics players that provide credit decisioning tools. When decisions about credit extension are informed by or fully based on AI algorithms, banks will need to demonstrate the fairness of such decisions and their compliance with customer protection rules. Compliance teams can inform assessments of these requirements, such as required investments in controls and the AI talent required to interpret algorithms’ output.

Environmental, social, and governance (ESG) offerings are another area of potential opportunity for collaboration. Institutions that aspire to bring attractive ESG offerings to market need well-designed processes for product creation and maintenance. Basic criteria include factors (and underlying data) used to construct ESG investment products that are transparent and reflective of the investment objectives described in the prospectuses. Strategy teams play a key role in defining ESG product initiatives based on market dynamics and client needs. Compliance teams working with strategy teams can provide insights on alignment of ESG factors with the declared investment objectives and regulatory guidance, as well as the processes for monitoring product performance and informing customers.

Compliance and strategy could collaborate to articulate the largest regulatory risks associated with products or segments that are new to the industry, growing in importance, or being considered as a new focus. Examples could include analytics or digital payments.

Compliance officers could regularly share with colleagues the latest regulatory developments in this space, including potential implications for a bank’s planned investment actions, if relevant. In addition, banks should consider explicitly designating compliance team members who will be on point to provide strategically informed compliance insights on fast-evolving areas that the institution has prioritized for potential investment. These people would have the dual mandate of being compliance officers while advising strategists in areas where the bank is exploring the potential for growth or an inorganic investment thesis. Banks can even consider forming a small compliance advisory team to provide such input as needed in areas of strategic significance. This team might sit either within the strategy or compliance functions, with a dotted-line relationship to the other group.

Resilience against geopolitical disruption

For global institutions, geopolitical forces up the ante, particularly when laws or regulations shift quickly in response to countries’ foreign-policy stances. Institutions with an international footprint have complicated links between countries. Rarely can such organizations disconnect rapidly from any given country, not least because of compliance requirements. The strategy function may lack routines for systematically analyzing and understanding geopolitical scenarios.

For example, companies doing business in Russia or with Russian entities when it invaded Ukraine in early 2022 had to quickly translate the implications of the sanctions that many other countries imposed on Russia. Predefined playbooks for handling similar geopolitical shocks would accelerate response and reduce the probability of any outsize operational losses or regulatory fines that might create opportunities in the defensive quadrant of the values matrix.

Given recent geopolitical shifts, strategy teams may be well advised to start building a planning capacity, with compliance teams included. Those engaged with strategy at the senior level, with participation from the senior level of the compliance function, can systematically develop and analyze a set of geopolitical scenarios. For example, scenarios might include imposition of sanctions or quickly exiting a country.

Improved productivity

Collaboration to improve process productivity delivers impact primarily on the value capture axis of the matrix. For example, the compliance team can suggest the productivity initiatives (e.g., streamlining compliance controls, suggesting process simplification ideas based on compliance risk assessments) that could lead to significant impact on margin or revenue growth, given that prioritization of productivity initiatives is key for value capture.

When strategy teams design operational productivity programs, they balance effectiveness and efficiency levers across thousands of individual processes. Compliance organizations are uniquely positioned to support these efforts based on their observation of issues and challenges across the organization. In addition, the compliance team can help structure companywide communication flows on process and control streamlining opportunities. For example, they may have data and insights from security breaches, fraud, suspicious activity, and anti-money-laundering (AML) flags, as well as insights from control testing. These insights can inform where to eliminate, establish, or maintain manual checks; eliminate overlaps in the scope of reviews; or reengineer processes more holistically.

At the start of any productivity improvement effort, banks have an opportunity to include compliance as part of the core team. Similarly, when deploying the agile approach to identify opportunities, compliance officers can be core to the team structure from the start. This collaboration enables the team to review prioritized processes for opportunities to streamline compliance risk assessments and identified overlapping controls.

As the productivity program establishes baselines—for example, collecting data to prioritize the highest-impact products, businesses, and processes to start with—compliance experts can help with specifying data types and inputs needed, especially in areas such as control performance, key risk indicators, or customer complaint themes. For prioritizing productivity initiatives, compliance experts can contribute insights related to control testing or compliance risk assessment.

Stronger programmatic M&A

The compliance team can also help the strategy and M&A teams generate differentiated insights on mergers and acquisitions. In particular, collaboration can help strengthen programmatic M&A strategies , which generate excess returns relative to peers because serial acquirers tend to grow faster and more profitably. 2 Among companies with revenue CAGR over 5 percent, our research has shown, those with programmatic M&A strategies generate shareholder returns 3.5 percentage points higher than for those growing organically.

Collaboration on acquisition-related themes enables both offensive and optimizing strategies. Organizations can generate differentiated insights for upside capture, such as compliance criteria integrated in M&A sourcing filters. They also can pursue the dual benefits of upside capture and downside protection, such as collaboration on postmerger decisioning and planning.

Successful execution requires strong M&A capabilities, and the compliance function has a key role to play in each capability, including M&A sourcing, due diligence, and integration planning and execution. To enable programmatic M&A, compliance can help design filtering criteria so target identification excludes companies with suspicious clients or that operate in jurisdictions with weak regulatory infrastructure. Strategy and compliance teams should also collaborate to ensure the filters stay calibrated to existing market conditions.

Collaboration on due diligence can include pressure-testing strategic and financial assumptions linked to compliance. Key questions to consider for accurate valuation and assessment of targets’ business models are whether the market sizing assumes no new restrictive regulation of the target’s core product and what it will cost to bring a target’s financial-crime controls in line with those of the acquiring bank.

During postmerger integration and planning, the compliance team can be a partner in deciding the nature and level of integration. In our experience, companies do make compliance part of premerger planning but frequently as a stand-alone workstream. However, the maturity of a target’s control infrastructure often has direct bearing on the right approach to business, process, and system integration. For example, limited control infrastructure and a history of regulatory relationship challenges may prompt the organization to pursue greater integration across functions in order to migrate the target’s businesses to the acquirer’s more controlled and mature environment.

Consider integrating the compliance team into the entire M&A deal workflow. Bringing compliance into the M&A deal workflow can be a simple change. For example, compliance officers can become permanent members of the deal team across the full deal life cycle, including deal identification (refining investment filters with compliance factors), due diligence (leading compliance-specific deep dives), and integration (using control performance to generate insights on the integration strategy).

Structural solutions to sustain and amplify collaboration impact

Walk a day in my shoes.

Strategists and compliance officers have not been natural bedfellows. Strategists may not fully grasp compliance-related risks, while compliance officers may not understand in detail competitor moves or friction that spurs clients to reduce their business. But in the world that lies ahead, mutual understanding will likely be foundational for gaining a competitive edge.

Life as a compliance officer

The compliance role has grown as regulatory frameworks and compliance requirements proliferate. Since 2010, more rules have been issued by the four regulatory agencies (Federal Reserve, OCC, FDIC and CFPB) than in the entire period since the creation of the Federal Reserve System in 1913 to 2010. Compliance officers must translate every new requirement into digestible obligations, alter policies and procedures accordingly (often individually for each product, business, and geography), and help the business side understand these obligations in the context of their processes. Failure to do so can result in large fines to the company, restrictions on business, and even liability of individuals including senior executives and board members.

Compliance officers view their core mission as protectors, so the business’s goals of serving clients better, growing, or improving productivity can easily be perceived as resistance to the compliance function’s mission.

Life as a strategist

Unaddressed market forces continually deplete profits , so strategists try to create and capture economic and social value sustainably in the face of uncertainty. As the pace of innovation and disruption accelerates, strategists’ role becomes ever more intense. They rely on insights into key driving factors to formulate powerful strategy, deep interpersonal engagement and debate from senior executives, and a mutual understanding that the business is prepared and willing to act on a strategy once adopted.

While strategists could benefit greatly from the insights supplied by the compliance function, they often struggle to see past the technical language of rules and regulations. They will likely be better able to appreciate the larger meaning behind compliance if they have information synthesized into terms they can apply to their process of strategy formulation.

Three main obstacles tend to hinder systematic collaboration between compliance and business. First, the compliance function is sometimes seen as lacking full understanding of the business, so the idea of collaboratively finding creative solutions never arises (see sidebar, “Walk a day in my shoes”). Second, the operating model, organizational structure, and talent often are not set up to support meaningful engagement that would allow working together. Third, processes and technology generally have not been designed to unlock and sustain such collaboration. Acting systematically in these three areas, banks can sustain and magnify the impact of the initial actions previously described.

Culture of collaboration

Culture is a key determinant of shifts in the collaboration model, but it is arguably the hardest structural dimension to change in a sustainable way. Banks can prepare the ground for larger change by introducing microhabits that start with understanding each other’s vantage point. As with many other aspects of cultural change, building such understanding is a top-down process. Two microhabits are essentials for cultivating mutual understanding:

• The right tone from the top . Senior executives, including heads of the business and functional leadership, should be fully aligned on the principle behind the operating model and reinforce its importance in their communications, decisions, and actions.
• Collaboration at the C-level . An alliance between the chief compliance officer and the chief strategy officer enable their teams to meet the goals of collaboration. Without the chemistry and meeting of minds at the top, simple process interventions won’t deliver meaningful results.

Talent and operating model

Meeting the need for compliance talent skilled in collaboration and strategy requires the right approach to recruiting and upskilling (such as learning pathways and job rotations). From the recruiting perspective, compliance functions may need to reassess their usual criteria for senior compliance hires, such as a legal background, in favor of more diversification and cross-pollination on the team. Recruitment of compliance leaders should leverage the full diversity of the risk and compliance professionals in the industry. Our recent research  indicates that 90 percent of the risk and compliance professionals in our data set did not start in risk roles.

In addition, given that value creation primarily happens within business units, compliance and strategy activities should reflect the needs of business units. Strategy and compliance teams can explicitly align on how to jointly serve relevant business units where needed. Such upfront alignment can then be translated into tactics for collaboration.

Underlying technology

More modular and integrated tech and data infrastructure can enable connectivity between the strategy and compliance systems. More specifically, investments in workflow capabilities would allow both compliance and strategy counterparts to collaborate in real time, assign tasks to each other, and leverage common data sources. Ideally, such systems are capable of ingesting compliance-related input such as data regarding future regulatory scenarios, the potential impact of geopolitical events, and the impact of control failures on M&A integration. The systems then can incorporate this knowledge into major scenario-planning or business valuation tools.

For example, a bank may design a platform for risk assessments where strategy and compliance have access to the same modules and analyses. Such a platform would source the data from business unit systems and allow the compliance officers to see the compliance assessments carried out in real time. This would have an additional benefit: minimizing the time spent on low-value tasks (reconciling data or replicating the analyses, for example). Instead, the teams could focus on jointly prioritizing key risks and on collaborating to select and implement mitigating actions.

Banks have a strong opportunity to realize impact through collaboration between their compliance and business strategists. Quick wins are possible, but banks wanting to unlock the full potential of such collaboration must consider how to build systems, processes, and foundational capabilities that will enable them to scale up their collaboration.

Irakli Gabruashvili is an associate partner in McKinsey’s New York office, where Ishaan Seth is a senior partner; Olivia White is a senior partner in the Bay Area office; and Alexis Yumeng Yang is a consultant in the Seattle office.

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Princeton engineering, can language models read the genome this one decoded mrna to make better vaccines..

By Scott Lyon

April 8, 2024

Princeton researchers led by Mengdi Wang have developed a language model to home in on partial genome sequences and optimize those sequences to improve function for the development of mRNA vaccines and other therapies. Illustration from Adobe Stock.

The same class of artificial intelligence that made headlines coding software and passing the bar exam has learned to read a different kind of text — the genetic code.

That code contains instructions for all of life’s functions and follows rules not unlike those that govern human languages. Each sequence in a genome adheres to an intricate grammar and syntax, the structures that give rise to meaning. Just as changing a few words can radically alter the impact of a sentence, small variations in a biological sequence can make a huge difference in the forms that sequence encodes.

Now Princeton University researchers led by machine learning expert Mengdi Wang are using language models to home in on partial genome sequences and optimize those sequences to study biology and improve medicine. And they are already underway.

In a paper published April 5 in the journal Nature Machine Intelligence, the authors detail a language model that used its powers of semantic representation to design a more effective mRNA vaccine such as those used to protect against COVID-19.

Found in Translation

Scientists have a simple way to summarize the flow of genetic information. They call it the central dogma of biology. Information moves from DNA to RNA to proteins. Proteins create the structures and functions of living cells.

Messenger RNA, or mRNA, converts the information into proteins in that final step, called translation. But mRNA is interesting. Only part of it holds the code for the protein. The rest is not translated but controls vital aspects of the translation process.

Governing the efficiency of protein production is a key mechanism by which mRNA vaccines work. The researchers focused their language model there, on the untranslated region, to see how they could optimize efficiency and improve vaccines.

After training the model on a small variety of species, the researchers generated hundreds of new optimized sequences and validated those results through lab experiments. The best sequences outperformed several leading benchmarks for vaccine development, including a 33% increase in the overall efficiency of protein production.

Increasing protein production efficiency by even a small amount provides a major boost for emerging therapeutics, according to the researchers. Beyond COVID-19, mRNA vaccines promise to protect against many infectious diseases and cancers.

Wang, a professor of electrical and computer engineering and the principal investigator in this study, said the model’s success also pointed to a more fundamental possibility. Trained on mRNA from a handful of species, it was able to decode nucleotide sequences and reveal something new about gene regulation. Scientists believe gene regulation, one of life’s most basic functions, holds the key to unlocking the origins of disease and disorder. Language models like this one could provide a new way to probe.

Wang’s collaborators include researchers from the biotech firm RVAC Medicines as well as the Stanford University School of Medicine.

The Language of Disease

The new model differs in degree, not kind, from the large language models that power today’s AI chat bots. Instead of being trained on billions of pages of text from the internet, their model was trained on a few hundred thousand sequences. The model also was trained to incorporate additional knowledge about the production of proteins, including structural and energy-related information.

The research team used the trained model to create a library of 211 new sequences. Each was optimized for a desired function, primarily an increase in the efficiency of translation. Those proteins, like the spike protein targeted by COVID-19 vaccines, drive the immune response to infectious disease.

Previous studies have created language models to decode various biological sequences, including proteins and DNA, but this was the first language model to focus on the untranslated region of mRNA. In addition to a boost in overall efficiency, it was also able to predict how well a sequence would perform at a variety of related tasks.

Wang said the real challenge in creating this language model was in understanding the full context of the available data. Training a model requires not only the raw data with all its features but also the downstream consequences of those features. If a program is designed to filter spam from email, each email it trains on would be labeled “spam” or “not spam.” Along the way, the model develops semantic representations that allow it to determine what sequences of words indicate a “spam” label. Therein lies the meaning.

Wang said looking at one narrow dataset and developing a model around it was not enough to be useful for life scientists. She needed to do something new. Because this model was working at the leading edge of biological understanding, the data she found was all over the place.

“Part of my dataset comes from a study where there are measures for efficiency,” Wang said. “Another part of my dataset comes from another study [that] measured expression levels. We also collected unannotated data from multiple resources.” Organizing those parts into one coherent and robust whole — a multifaceted dataset that she could use to train a sophisticated language model — was a massive challenge.

“Training a model is not only about putting together all those sequences, but also putting together sequences with the labels that have been collected so far. This had never been done before.”

The paper, “A 5′ UTR Language Model for Decoding Untranslated Regions of mRNA and Function Predictions,” was published in Nature Machine Learning. Additional authors include Dan Yu, Yupeng Li, Yue Shen and Jason Zhang, from RVAC Medicines; Le Cong from Stanford; and Yanyi Chu and Kaixuan Huang from Princeton.

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Quotient Sciences' Vanessa Zann on the company's fascinating updates in drug development

08-Apr-2024 - Last updated on 09-Apr-2024 at 08:03 GMT

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With her extensive experience from AstraZeneca and at Quotient Sciences, Zann offers her perspectives on drug development strategies and the transformative potential of the Translational Pharmaceutics delivery platform.

Reflecting on her tenure at AstraZeneca, Zann emphasizes one critical consideration developed during her interactions with her drug development colleagues, “From an oral absorption perspective, it’s important to exercise caution when reviewing non-human data. We've all seen the Grass and Sinko and Musther et al., plots, so we know animals are frequently poor predictors of performance in humans. What really matters is the human absorption data, and the sooner we can see this, the better.”

This perspective underscores the paramount importance of human data in guiding drug development and optimization decisions, a principle she carries into her current role at Quotient Sciences.

Compelling case studies

Zann shares compelling case studies that exemplify innovative approaches in drug development. One such case study focuses on a groundbreaking program targeting amyotrophic lateral sclerosis (ALS). In response to initial preclinical indications of solubility-limited exposures, the team crafted an innovative design for the First-in-Human study (FiH) to enable head-to-head testing of three enhanced formulations within the single ascending dose study.

Another intriguing case study describes the development of a gastro-retentive combination drug product for treating depression. “We knew from the compound’s properties that there was an absorption window necessitating ongoing delivery to the upper gastrointestinal tract. To achieve a patient acceptable dosage form, we had to develop a gastro-retentive formulation. To optimise the drug delivery characteristics of the dosage form, we established and clinically evaluated a flexible formulation ‘Design Space’ to allow us to iteratively vary dose and release rate from the swellable tablet technology. This innovative approach identified an optimized product to sustain drug delivery to absorptive regions of the gut and to achieve the desired reduction in dosing frequency. Ultimately this product will enhance patient compliance and treatment efficacy in individuals with depression.” Zann explains.

Abuse-resistant opioids 

Furthermore, Zann discusses an ambitious project aimed at creating abuse-resistant opioid pain medication. Using prodrugs only converted to the active for in the presence of trypsin combined with trypsin inhibitors to limit this conversion, the project devised a multi-pill technology capable of delivering therapeutic levels of oxycodone while eliminating abuse potential.

By advancing approaches such as this, researchers aim to create medications that deliver pain relief while minimizing the risk of misuse and addiction. This approach represents a significant step forward in addressing the opioid crisis and improving patient safety. Looking ahead, Zann highlights the role of artificial intelligence (AI) in advancing drug development and is already working on new chemical entities emerging from drug discovery and entering clinical development. With Quotient Sciences at the forefront of AI integration, she emphasizes the further potential for AI to streamline data analysis, predict formulation outcomes, and accelerate drug development processes. As AI continues to evolve, it promises to revolutionize pharmaceutical research and development, ushering in a new era of innovation and efficiency.

In summary, Zann's insights shed light on the cutting-edge advancements and innovative strategies shaping the future of pharmaceutical research and development. From leveraging human data to develop more effective treatments, to harnessing the power of AI to accelerate drug development, the field is poised for unprecedented progress. As Quotient Sciences continues to push the boundaries, the possibilities for improving patient outcomes and addressing unmet medical needs are limitless.

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