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INTRODUCTION TO CLINICAL RESEARCH Lecture 1: Who, What, Why and Where of Clinical Research - PowerPoint PPT Presentation

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INTRODUCTION TO CLINICAL RESEARCH Lecture 1: Who, What, Why and Where of Clinical Research

Introduction to clinical research lecture 1: who, what, why and where of clinical research richard j. barohn, m.d. professor and chairman department of neurology – powerpoint ppt presentation.

  • Richard J. Barohn, M.D.
  • Professor and Chairman
  • Department of Neurology
  • Director, General Clinical Research Center
  • University of Kansas Medical School
  • August 24, 2006
  • Types of clinical research
  • Retrospective looking back at data previously collected
  • - Case Reports
  • - Case Series
  • Prospective make plan for future data collection
  • - Observational
  • - Interventional
  • - Device/technique
  • Can involve direct participant contact
  • - Measure a clinical end-point
  • Obtain tissue samples from participant to study in the laboratory
  • Can be data-mining of clinical databases
  • - Never see participant
  • - Example Medicare database
  • Survival (mortality)
  • Physiologic parameter
  • Example quantitative strength, breathing (vital capacity)
  • Clinical scales
  • Example Mini Mental Status
  • Blood or other body tissue measurement
  • Example - Glucose Level
  • - Hormone Level
  • Open-label Trial
  • Everyone receives research intervention
  • Controlled Trial
  • Some receive research intervention, some do not
  • Control group - Ones that do not receive research intervention
  • Control group can be getting another intervention
  • Comparing new drug to older one
  • Or control group can get placebo (inactive intervention)
  • Randomized Trials
  • Participants randomly allocated to active intervention or control group
  • Blinded usually double blind
  • Doctor and participant do not know which group subject is in
  • Gold Standard Randomized Double-Blinded Controlled Trial
  • Most proceeded by beneficial results in laboratory models
  • All multicenter with other ALS centers
  • COX-2 inhibitor (glutamate inhibitor) (MDA)
  • Celebrex trial just completed no benefit
  • ? improves strength in athletes (NIH)
  • Minocycline oral (cell death inhibitor) (NIH)
  • Ceftriaxone intravenous (cell death inhibitor) (NIH)
  • CoQ10 (antioxidant) (NIH)
  • Arimoclomol (increases heat shock protein) (Biotech investigator initiated)
  • Celebrex/creatine vs mino/creatine (ALSA)
  • Pre-Clinical Animal and In Vitro Lab Studies
  • Phase I Safety (normals disease)
  • Phase II Preliminary Efficacy Data with
  • additional safety
  • usually lt 100 patients
  • Phase III Pivotal efficacy trial
  • Large, often multicenter
  • Phase IV - Post-marketing
  • In Academic Health Centers
  • Faculty MD, DO, PhD are Principal Investigators and Co-Investigators in Schools of Medicine, Nursing, Allied Health
  • Trainees (students, residents, fellows) work under Faculty
  • Outside of Academic Health Centers
  • Private practice health care providers
  • Pharmaceutical companies, example Quintiles
  • Biomedical device companies
  • Investigator
  • Clinical Research Coordinators
  • (Example nurse, respiratory therapist, RD)
  • Clinical Research Evaluator
  • Research Assistant
  • Biostatistician
  • Data Manager
  • Research Pharmacy
  • If laboratory based
  • Lab research personnel (students, post doctorate, technicians)
  • Federal Grants
  • Example National Institutes of Health
  • FDA-Orphan Drug Grant Program
  • Foundations
  • Example Muscular Dystrophy Association
  • Internal-funding at medical center
  • Example Research Institute of KUMC
  • Private Donations
  • Non-Funded Research
  • Local Institutional Support
  • KUMC Research Institute
  • Disease-Related Foundations
  • Standard Research Grants
  • Career Development Grants
  • NIH (NIH.gov)
  • Apply to NIH for
  • K23 Clinical Research
  • K08 Lab/Translational
  • R03 Pilot Program
  • R21 Developmental/Exploratory
  • Institutional Awarded Training Grants
  • T32 Training
  • K12 Career Development
  • VA Career Development Awards
  • Merit Grants
  • GOAL RO-1 THE BIG ONE
  • Food Drug Administration (FDA)
  • PI applies to get IND for drug trial
  • Local Human Subjects Committee (Institutional Review Board)
  • Local HIPPA Compliance Program
  • General Clinical Research Center
  • Research Subject Advocate
  • Safety Monitors
  • Data Safety Monitoring Boards
  • Local KUMC DSMB
  • National NIH DSMB
  • Research Institute Clinical Trials Office
  • Serve as centralized sponsor contact point for KUMC
  • Prepares consent with PI input
  • Prepares and negotiates trial budgets
  • Submits protocol/consent to HSC if there is a sponsor
  • Contact Laurie Kemble at 588-1242 or http//www2.kumc.edu/researchinstitute/
  • Human Subjects Committee
  • KUMCs Institutional Review Board
  • Committed to ethical, legal and safe conduct in all research involving human participants
  • Meets 2nd and 4th Tuesdays
  • Submissions by noon Friday, 7 business days prior to meeting
  • Submission of materials
  • Contact Karen Blackwell at 588-0942 or http//www.kumc.edu/hipaa/
  • Focus on steering mechanism not the
  • drive train or brakes, as they are
  • not usually accessible to mentors.
  • The mentor should
  • Be interested
  • Have experience
  • Be available
  • Limit number of mentees
  • Commit substantial time
  • Be vigilant but not intrusive
  • In academic health centers
  • Departmental clinical space
  • Designated research space
  • Example GCRC
  • Hoglund Brian Imaging Center
  • Veterans Administration Medical Centers
  • Hospitals not affiliated with AHC
  • NIH in Bethesda intramural
  • Private health care provider offices
  • Industry offices
  • Advance science/improve knowledge
  • Obtain access to a potential Rx at the earliest possible time
  • Current Rx not working
  • It helps maintain hope - better than not doing anything
  • Desire to meet and speak with researchers
  • To help others
  • Reimbursement to subject/patient
  • Painful unpleasant procedures
  • Fear of going off current medication
  • New treatment may not be better
  • Time commitment/travel
  • Side effects
  • Fear of the unknown
  • Fear of being assigned to placebo
  • They accept the disease is their fate
  • Efforts futile
  • Privacy concerns publication, etc.
  • Resentment of medical personnel
  • Distrust of science community
  • Dont want to be a guinea pig
  • Dont agree with focus of research
  • Long wait to get research results
  • Be considered a partner in the research
  • Be treated with respect / taken seriously, kept informed and up-to-date
  • Do not want to be talked down to
  • Full disclosure of side effects
  • Option to stop involvement in study
  • Support from research team - availability
  • After study, want to know results and if they were on drug or placebo
  • Realistic idea when results will be available
  • No cost to participant
  • Confidentiality
  • Enough time and comfortable area
  • To ask questions
  • In which to do the study
  • A NIH-supported multidisciplinary research unit which facilitates investigator-initiated clinical studies and trials conducted by full-time faculty of the AHC.
  • Provides clinical research infrastructure to investigators who receive funding from federal agencies, private foundations, other peer-reviewed sources.
  • Also, can include investigator initiated unfunded pilot studies and industry sponsored studies.
  • This is at no cost to the PIs for Investigator-Initiated Trials
  • Provide clinical investigators from the SOM, SON, and SOAH with a modern, state-of-the-art facility in which clinical research could be conducted
  • Enhance multidisciplinary research across departments and the three schools
  • Enable and train junior faculty and trainees to become more involved in clinical research
  • Apply for federal funding to support the GCRC
  • Outpatient Unit
  • Inpatient Unit
  • Scatter Beds
  • Metabolic Kitchen
  • Informatics Core
  • VOTING MEMBERS
  • Matthew Mayo, PhD
  • Jared Grantham, MD
  • Marge Bott, RN, PhD
  • Richard McCallum, MD
  • Stephen Williamson, MD
  • Richard Dubinsky, MD
  • Barbara Lukert, MD
  • Kevin Latinis, MD, PhD
  • Debra Sullivan, PhD, RD, LD
  • Patrick Moriarty, MD
  • Jo Ann Harris, MD
  • John Ferraro, PhD
  • Andrea Charbonneau, MD
  • Kathryn Ellerbeck, MD
  • Ossama Tawfik, PhD, MD
  • Barbara Quaney, PT, PhD
  • Kathleen Gustafson, PhD
  • NON-VOTING EX OFFICIO MEMBERS
  • Barbara Atkinson, MD Executive Dean SOM
  • Richard J. Barohn, MD Program Director
  • Curt Hagedorn, MD Associate Director
  • Jeff Burns, MD Assistant Director
  • Patricia Kluding, PT, PhD Assistant Director
  • Paul Terranova, PhD
  • Susan Schmitz, BA, CCRC Administrative Director
  • Judy Otey, RN, BSN Nurse Manager
  • Ed Ellerbeck, MD, MPH
  • Jon Jackson
  • Jo Denton, MSN
  • Laurie Kemble, BS, CRT
  • For GAC approved studies
  • Space to see patients
  • Biostat support study design
  • Data management
  • Nurse support
  • Administrative support
  • Specimen collection/storage
  • Common equipment
  • No cost for above services to PIs on investigator initiated studies
  • Industry sponsored with charges for space/resources
  • Space/resources for industry studies
  • Permanent space for research coordinators
  • Overnight stay on GCRC unit
  • GCRC Planning Committee formed 2002
  • Construction/Remodeling began June 1, 2004
  • Completed October 2004
  • 6, 000 square feet in Delp
  • Announce GAC will accept research applications from investigators, September 2004
  • Began doing studies on GCRC January 2005
  • Approval of 53 on-going studies by GAC as of June 2006
  • GCRC NIH grant submitted June 1, 2006
  • 2 million (direct costs) per year for 3 years
  • Contact Judy Otey, RN, BSN
  • GCRC Administrative Director
  • 913-588-0984 alt. 2460
  • jotey_at_kumc.edu
  • Nicole Ladesich, BS
  • GCRC Senior Coordinator
  • 913-588-0976 alt. 2294
  • nladesich_at_kumc.edu
  • Visit Website http//gcrc.kumc.edu
  • Recruiting and retaining researchers
  • Explosion in clinical demands, reduced financial margins ? limit time, diluted value
  • Regulatory burden
  • Fragmented training
  • Complexity of training
  • No real HOME for clinical researchers
  • Limitations / barriers due to NIH funding mechanisms, review, program structures
  • Clinical Research covers all studies of diseases and trials of
  • treatments in human subjects
  • Translational Research describes the steps between a
  • fundamental discovery and its application in clinical
  • medicine. For example
  • Testing a new anti-cancer drug in humans for the first time
  • Identifying best practices in the diagnosis, prevention, or management of a disease and enhancing their adoption by the community
  • Purpose Forge a transformative and integrative academic home for clinical and translational science
  • The home must be a Center, Department, or Institute.
  • Encompass all components of clinical research (education, career development, clinical research infrastructure)
  • Promote multidisciplinary research teams
  • Create an incubator for innovative research tools
  • Catalyze the application of new knowledge to clinical practice
  • Degree granting capabilities in Clinical Research
  • Masters and/or PhD
  • No current GCRC funding
  • Current K12 applicability?
  • Small pool of clinical mentors, current clinical R01s
  • Limited culture for CR
  • GCRC infrastructure
  • Institutional support
  • Research Institute
  • SOM / SON / SOAH
  • Bioinformatics Center (Mayo)
  • K-BRIN (Hunt)
  • KU Lawrence (Georg and others)
  • Intro to CR Course
  • K30 (MSCR program)
  • KU Lawrence
  • Life Span Institute
  • Drug Development
  • Introduction to CR Course
  • No Clinical T32
  • Letter of Intent February 27, 2006
  • Grant Application March 27, 2006
  • Planning grant 150,000 for 1 year
  • Full CTSA up to 6 million with pediatrics
  • 4 million without pediatrics
  • Existing K30, T32, and GCRC are in addition
  • 5 year award RFA offered annually
  • Goal 60 CTSAs to be awarded by 2012
  • Will replace all GCRCs and NCRR / Roadmap K12s
  • Planning Steering Committee
  • Barbara Atkinson, MD
  • Richard J. Barohn, MD
  • Governance Planning Sub-Committee
  • Grant Writing Planning Sub-Committee
  • Lauren Aaronson, PhD, RN
  • Education Planning Committee
  • Chair Ed Ellerbeck, MD, MPH
  • Clinical Research Resources Planning Committee
  • Regulatory Planning Committee
  • Jim Voogt, PhD
  • John Finley, JD, MPH
  • Novel Methods Translational Technologies Planning Committee
  • Curt Hagedorn, MD
  • Health Disparities Research Planning Committee
  • Patricia Thomas, MD
  • Kirby Randolph, PhD
  • Community Participant Planning Committee
  • Joshua Freeman, MD

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Preparing the Research Presentation

If you have never presented a paper at a scientific meeting, you should read this article. Even if you have presented before, it is likely that this article contains information that will improve your presentation. This article contains a set of practical, proven steps that will guide your preparation of the presentation. Our assumptions are that you will schedule appropriate planning and preparation time, are interested in doing the best job possible, and know that a quality presentation is a combination of good research and communication skills. This and subsequent articles will focus on planning, preparation, creating visual aids (slides), and presentation skills for a scientific presentation. The intent of this series of articles is to help you make a favorable impression at the scientific meeting and reap the rewards, personal and professional, of a job well done.

To begin with, you need to create an outline of the topics you might present at the meeting. Your outline should follow the IMRAC format (introduction, methods, results, and conclusion). This format is chosen because your audience understands it and expects it. If you have already prepared a paper for publication, it can be a rich source of content for the topic outline.

To get you started, we have prepared a generic outline  to serve as an example. We recognize that a generic outline does not necessarily adapt to all research designs, but we ask you to think, "How can I adapt this to my situation?" To help you visualize the content you might include in the outline, two types of examples have been included, one that describes a cross-sectional study using a survey methodology (example A), and a second using a combination of a case-control and cohort designs (example B).

Use the Preparing the Research Presentation Checklist  to assist you in preparing the topic outline.

introduction to clinical research design

Introduction to Clinical Research Design

Mar 30, 2019

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Introduction to Clinical Research Design. Lee E. Morrow, MD, MS Assistant Professor of Medicine Creighton University. Descriptive Describe incidence of outcomes over time Case Reports Case Series Registries Cross Sections. Analytic Analyze associations between predictors and outcomes

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Presentation Transcript

Introduction to Clinical Research Design Lee E. Morrow, MD, MS Assistant Professor of Medicine Creighton University

Descriptive Describe incidence of outcomes over time Case Reports Case Series Registries Cross Sections Analytic Analyze associations between predictors and outcomes Observational Cohort Studies Case-Control Studies Experimental Clinical Trials Clinical Research Designs

Descriptive Studies • Often a first step in research • Doesn’t always have a specific hypothesis to be tested • Causality usually cannot be determined • Examples: • Case Reports/Series • Registries • Cross Sectional Studies

Case Reports/Series • Definition: A single/series of patients with or without a disease or exposure of interest for whom data are collected in any fashion • Sources: Clinics, hospitals, disease registries • Limitations: Not randomly selected, bias due to selection factors inherent in the source, not representative of the population from which they are selected

Case Reports/Series • Benefits: Easy to do, useful for exploring relationships and/or generating hypotheses • Key Point: Associations seen in case series are highly likely to be biased and frequently do NOT hold up in more rigorous studies

Cross-Sectional Studies • Definition: A study based on a sample selected at one point or period in time Risk Factor Present Risk Factor Absent Population

Cross-Sectional Studies • Definition: A study based on a sample selected at one point or period in time Risk Factor Present Risk Factor Absent Sample Population

Cross-Sectional Studies • Definition: A study based on a sample selected at one point or period in time Disease No Disease Risk Factor Present Disease No Disease Risk Factor Absent Sample Population

Cross-Sectional Studies • If looking at a specified moment in time: point prevalence • If looking at a specified moment in time plus all new cases during the specified time period: period prevalence • If looking only at new cases during the specified time period: incidence

Cross-Sectional Studies Which cases are included in 7/1/02 point prevalence? Which cases are included in 7/1/02-6/30/03 period prevalence? Which cases are included in incidence? 1 2 3 4 5 6 7 8 9 7/1/02 6/30/03

Cross-Sectional Studies 7/1/02 point prevalence cases: 1, 2, 8 7/1/02-6/30/03 period prevalence cases: 1, 2, 3, 4, 6, 8, 9 incidence cases: 3, 4, 6, 9 1 2 3 4 5 6 7 8 9 7/1/02 6/30/03

Cross-Sectional Studies Assuming N=100, calculate the 7/1/02 point prevalence. Calculate the 7/1/02-6/30/03 period prevalence. Calculate the incidence rate. 1 2 3 4 5 6 7 8 9 7/1/02 6/30/03

Cross-Sectional Studies 7/1/02 point prevalence: 3% 7/1/02-6/30/03 period prevalence: 7% incidence rate: 4% 1 2 3 4 5 6 7 8 9 7/1/02 6/30/03

Cross-Sectional Studies • Limitations: • Exposure and outcome are assessed at the same time by the investigator (no temporality) • Sample selection is not based on exposure or outcome • Prevalence estimate is affected by duration of disease: disease with longer duration is more likely to be detected • Must consider “at risk” population only

Cross-Sectional Studies • Benefits • Easy • Cheap • Gives a “snap-shot” of exposure and outcome • Good for hypothesis generation

Analytic Studies • Involve a specific hypothesis that can be tested using a statistical model • Involve assessing exposures as a predictor of outcomes • Examples: • Observational: Cohort Studies, Case-Control Studies • Experimental: Clinical Trials

Cohort Studies • Involve following a group (cohort) of subjects over time • Usually analytic but may be descriptive • Was a treatment specifically initiated for evaluation? • No: Simple Cohort Study • Yes: Clinical Trial • Randomized • Non-Randomized

Cohort Studies • Prospective Cohort Studies • Investigator defines sample and predictor variables before any outcomes have occurred • Retrospective Cohort Studies • Investigator defines sample and collects information about predictor variables after the outcomes have occurred

Prospective Cohort Studies Is a given Risk Factor associated with a given Disease? The Present Risk Factor Present Risk Factor Absent Population

Prospective Cohort Studies Is a given Risk Factor associated with a given Disease? The Present Risk Factor Present Risk Factor Absent Sample Population

Prospective Cohort Studies Is a given Risk Factor associated with a given Disease? The Present The Future Risk Factor Present Disease No Disease Disease No Disease Risk Factor Absent Sample Population

Retrospective Cohort Studies Is a given Risk Factor associated with a given Disease? The Present Disease No Disease Disease No Disease

Retrospective Cohort Studies Is a given Risk Factor associated with a given Disease? The Past The Present Risk Factor Present Disease No Disease Disease No Disease Risk Factor Absent Sample Population

Cohort Studies in General • Strengths • Powerful strategy for directly measuring the incidence of a disease • Can examine multiple outcomes and multiple exposures • Easier to establish temporal relationship: improves inference for causality

Cohort Studies in General • Weaknesses • Attrition of the sample • Level of exposure may change over time • Inability to identify presence of confounders and effect modifiers • Susceptible to follow-up bias: there may be a difference in the exposure-disease relationship for those who follow-up and those who do not • Cost and feasibility vs. representativeness: general population sample vs. restricted cohort sample

Prospective Cohort Studies • Strengths • Allows opportunity for complete and accurate measurement of risk factors • Uniquely valuable for studying the antecedents of fatal diseases • End-point unknown: can take a long time for sufficient number of cases to develop • Observer bias • Weaknesses • Expensive and inefficient for rare diseases • Observer bias

Retrospective Cohort Studies • Strengths • Much less costly and time consuming • Observer bias • Weaknesses • Less control over the nature and quality of predictor variable data collected • Incomplete data sets • Observer bias, recall bias

Risk Ratios in Cohort Studies • The Risk Ratio (RR) is the ratio of the incidence of disease in exposed persons to the incidence of disease in non-exposed persons Cumulative Incidence in Exposed RR = Cumulative Incidence in Non-Exposed

Risk Ratios in Cohort Studies • RR calculation requires incidence data • Used in cohort and intervention studies • Not used in Case-Control Diseased - + a b + a/(a+b) RR = Exposed c/(c+d) c - d

Risk Ratios in Cohort Studies • Is a measure of the strength of association between exposure and outcome: does not imply causality…

Case-Control Studies • Compares people with disease (cases) to people without disease (controls) with respect to history of exposure • If exposure is different between cases and controls, an association exists between exposure and disease • Cases must represent the population of all cases while controls must represent the population of all non-diseased

Case-Control Studies The Present Population with Disease Population without Disease

Case-Control Studies The Present Population with Disease Risk Factor Present Risk Factor Absent Population without Disease

Case-Control Studies The Present Select Cases Population with Disease Risk Factor Present Risk Factor Absent Select Controls Population without Disease

Case-Control Studies The Present The Past D+/RF+ D+/RF- Population with Disease Risk Factor Present Risk Factor Absent Population without Disease D-/RF+ D-/RF-

Case-Control Studies • Strengths • Shorter study period is possible • Rare diseases are more easily studied • Less expensive • Multiple risk factors may be studied • Particularly useful for studying new diseases about which little is known

Case-Control Studies • Weaknesses • Choice of appropriate controls is usually very difficult (selection bias) • Cases and controls do not usually come from the same population (selection bias) • May be difficult to assess whether exposure preceded disease (recall bias) • Incidence rates cannot be calculated directly

Odds Ratios in Case-Control Studies • The Odds Ratio (OR) provides an estimate of the Risk Ratio (RR) for Case-Control studies • OR is a good estimate of the RR if the disease is “rare” (incidence <10% per year in the population) • Is a measure of the strength of association between exposure and outcome: does not imply causality…

Nested Case-Control Studies • Select disease cases from within a cohort study • Controls are selected from non-diseased cases within the same cohort, within the same time period as the cases develop • If controls are randomly selected from within the cohort (i.e.: includes diseased subjects in the case group and the control group) it is a Case-Cohort Study

A Few Words About Controls • The most difficult aspect of Case-Control Studies is selecting appropriate controls • Matching is often used to eliminate the effect of potential confounders • Technically speaking, matching reduces the variance of the OR! • Matching is difficult to do correctly and may paradoxically worsen analysis problems if done incorrectly • Impossible to match for unknown confounders

Clinical Trials • Definition: A clinical trial is a scientific experiment involving human subjects which is designed to evaluate the effects of intervention(s) against a particular disease in order to elucidate the most appropriate care for future subjects

Clinical Trials • Controlled* or Uncontrolled • Is there a concurrent comparison group? • Randomized* or Nonrandomized • Are subjects randomly allocated to the control and experimental groups? • Parallel Group or Crossover • Parallel group implies each subject receives only one of the interventions • Crossover implies each subject receives successively each of the interventions *Hence the terminology RCT

Clinical Trials: Randomization • Participants are randomly assigned to “Exposure” or “No Exposure” • Randomization refers to assigning subject to an intervention arm without regard for baseline characteristics • Goal of randomization is to equalize all other exposures that may confound or bias the association between Treatment and Outcome

Clinical Trials: Blinding • Single Blinding: examiners do not know treatment assignment • Double Blinding: examiners and subjects do not know treatment assignment • Triple Blinding: examiners, subjects, and statisticians do not know treatment assignments • Blinding is not always possible…

Clinical Trials • Advantages • Minimizes confounding and bias through randomization • Allows clear assessment of temporal association • Permits a test of causality between exposure and disease

Clinical Trials • Disadvantages • Ethical considerations of treatment or with-holding treatment • Harms (drug side effects, emotional distress) may outweigh benefits • Expensive and time-consuming • Loss to follow up • Non-adherence to group assignment • Possible early termination • Cannot always randomize an exposure

Quasi-Experimentation • This is essentially a clinical trial without randomization • Not possible to randomize: patients being enrolled in a rare disease trial at a site which does not have access to a given intervention • Not ethical to randomize: patients with cancer who have already failed the chemo in one arm of a trial cannot ethically be randomized to that arm • Uses statistical deductive processes to rule out threats to plausibility • Causal inference is less strong

Factorial Designs Intervention - X a b Y • This is essentially an attempt to evaluate multiple interventions concurrently • Given costs and inconvenience of recruiting, this is particularly appealing • Not a valid model if interaction, adds complexity, potential for polypharmacy, reviewer skepticism Intervention c - d CellIntervention a X + Y b Y + Placebo c X + Placebo d Placebo

Example 1: Design Type? • Investigators obtained lists of RNs age 25-42 in the 11 most populous U.S. states • They mailed baseline questionnaires about diet and other risk factors • Follow-up questionnaires were sent every 2 years for 20 years assessing additional risk factors and the development of disease outcomes

Example 1: Nurses’ Health Study • Prospective Cohort Study • Assembled a cohort • Assessed baseline risk factors • In the future assessed disease outcomes • Repeated Cross Sectional Study • Described changes over time in characteristics of the same study population

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Clinical Trial Infographics

Free google slides theme, powerpoint template, and canva presentation template.

These Clinical Trial Infographics are simply great for medical purposes: talking about treatments, steps, and diseases is simple if you use these timelines, arrows, bars and circle charts, banners and text blocks.

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  1. Clinical Research Presentation

    Clinical Research Presentation. Sep 16, 2009 • Download as PPT, PDF •. 49 likes • 28,400 views. AI-enhanced description. D. deepikashankar. Clinical research involves conducting research studies in human volunteers to answer health questions and find new treatments. It typically involves several phases from preclinical testing in animals ...

  2. Introduction to clinical research

    Introduction to clinical research. Clinical research involves systematic studies in human subjects to improve quality of life. Clinical trials are a form of clinical research that experimentally tests medications, devices, or biologics to evaluate safety and effectiveness. There are different phases of clinical trials, from small early phase ...

  3. INTRODUCTION TO CLINICAL RESEARCH

    Introduction Clinical research: Is the scientific study that involve people. • Individual volunteer to participate in carefully conducted studies which ultimately uncover improved methods and knowledge on screening, diagnosis, treatment and prevention of diseases. INTRODUCTION 4. 5.

  4. PDF INTRODUCTION TO CLINICAL RESEARCH

    July 2013 JHU Intro to Clinical Research 31 Main Points Once Again A clinical investigation is a search for truth - how a treatment affects population, not only your sample. ... Bandeen-Roche_Scientific Concepts for Clinical Research_Lecture 1 2013.ppt [Compatibility Mode]

  5. Top 10 Clinical Trials PPT Templates with Samples and Examples

    Typically, trials progress through distinct phases: Phase 1: Small-scale studies assess safety and dosage in healthy volunteers. Phase 2: Larger groups with the target condition receive the intervention, evaluating its efficacy and safety. Phase 3: Even larger trials confirm effectiveness and compare the intervention to existing treatments or ...

  6. PPT

    Presentation Transcript. This Course Will Introduce You To: • The basics of clinical research, types of clinical trials and why clinical research is necessary. • Good Clinical Practice and Good Laboratory Practice that guide the conduct of clinical research. • The importance of protecting participants and the informed consent procedures.

  7. PDF Lesson 1: Clinical Trials Overview

    therapies for treating these diseases. Clinical trials represent an essential component of evidence based medical research. Clinical trials are research studies involving people (healthy volunteers or patients) that test the safety and efficacy of a new treatment. A 'treatment' in this context could mean: A medicine.

  8. PDF Understanding the Clinical Research Process and Principles of Clinical

    2.Possible side effects of experimental vaccines could include fever, chills, rash, aches and pains, nausea, headache, dizziness, and fatigue. Injections can cause pain, soreness, redness, and swelling on the part of the body where the vaccine shot is given. Clinical Research Activity. With your group:

  9. PDF Clinical Trials 101

    Justify the number of subjects, sample size. Have a statistical plan. Measurable results rather than plausible reasoning are required to support conclusions. Retrospective. Participants are selected on the basis of presence or absence. of an event/condition of interest. Subjects can be identified from hospital records or other data sources.

  10. PPT

    INTRODUCTION TO CLINICAL RESEARCH Lecture 1: Who, What, Why and Where of Clinical Research Richard J. Barohn, M.D. Professor and Chairman Department of Neurology - A free PowerPoint PPT presentation (displayed as an HTML5 slide show) on PowerShow.com - id: 3bcf47-NDFmM

  11. Clinical Research Trial Stages Powerpoint Presentation Slides

    Content of this Powerpoint Presentation. Slide 1: This slide introduces Clinical Research Trial Stages. State your company name and begin. Slide 2: This slide shows the various steps involved in the clinical trial process. Slide 3: This slide indicates the key steps involved in the clinical drug investigation process.

  12. PPT

    Human Immunology Research Office • To request assistance: • Contact office to set up meeting to discuss project, assistance requested, etc • Complete research outline (template will be supplied by the office) • Contact information: Location: E1540 BST Phone: 412-624-6611 Email: [email protected].

  13. 210+ clinical research PPT Templates

    clinical research PPT Templates Download over 6,300+ complete free templates in high resolution. Ready-Made Slide Variety of templates for each industries. ... Medical research PowerPoint Presentations Samples. Built-in custom color palette Data charts (editable via Excel) 100% vector (fully editable maps, infographic, icons)

  14. Preparing the Medical Research Presentation

    To begin with, you need to create an outline of the topics you might present at the meeting. Your outline should follow the IMRAC format (introduction, methods, results, and conclusion). This format is chosen because your audience understands it and expects it. If you have already prepared a paper for publication, it can be a rich source of ...

  15. Clinical Research PowerPoint and Google Slides Template

    Our presentation template for MS PowerPoint and Google Slides is the perfect pick to present information in a well-structured fashion. Usage This 100% editable deck is ideal for medical researchers and will help them illustrate the types, objectives, benefits, and widespread community of clinical research.

  16. Top 20 PowerPoint Templates to Create a Clinical ...

    PowerPoint presentations can and should be used by all members of the clinical development team including the principal investigator, site staff, and central laboratory. ... Template 12: Drug Discovery And Clinical Research PPT Slide . This PowerPoint presentation template can help you provide an in-depth clinical development business strategy ...

  17. Free Clinical Trial Powerpoint Template

    Clinical and pharma icons. To make your presentation slides more appealing, this template has medical icons on it so you can use them as visual aids during the explanation of each clinical trial phase. Get your presentation custom designed by us, starting at just $10 per slide. STEP 1. UPLOAD PRESENTATION.

  18. PPT

    Mar 30, 2019. 730 likes | 898 Views. Introduction to Clinical Research Design. Lee E. Morrow, MD, MS Assistant Professor of Medicine Creighton University. Descriptive Describe incidence of outcomes over time Case Reports Case Series Registries Cross Sections. Analytic Analyze associations between predictors and outcomes. Download Presentation.

  19. Clinical Trials

    Clinical Trials - An Introduction. Oct 10, 2011 •. 449 likes • 196,945 views. Dr Purnendu Sekhar Das. This presentation will give an overview of the Clinical Research/Drug Development and licensing (US FDA) process. Please feel free to provide feedback. Read more. Health & Medicine Business. 1 of 51.

  20. 74 Best Clinical Research-Themed Templates

    74 Best Clinical Research-Themed Templates. CrystalGraphics creates templates designed to make even average presentations look incredible. Below you'll see thumbnail sized previews of the title slides of a few of our 74 best clinical research templates for PowerPoint and Google Slides. The text you'll see in in those slides is just example ...

  21. Free Research Google Slides and PowerPoint templates

    Download the "Endometrial Cancer Detection Breakthrough" presentation for PowerPoint or Google Slides. Treating diseases involves a lot of prior research and clinical trials. But whenever there's a new discovery, a revolutionary finding that opens the door to new treatments, vaccines or ways to prevent illnesses, it's great news. Should ...

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    Free Google Slides theme, PowerPoint template, and Canva presentation template. Detail the latest research in the field of medicine on these slides and let the community know! Going back to basics, this template is formal and simple. There're mostly rectangular shapes and enough room for your own content.

  23. Clinical Research

    Diabetes clinical research ppt powerpoint presentation model layout. Slide 1 of 2. Researcher icon for performing clinical trail. Slide 1 of 2. Half yearly clinical research roadmap for human medicine. Slide 1 of 7. Drug progress model template powerpoint templates microsoft. Slide 1 of 5. Research icon science experiment test tubes.

  24. Clinical Trial Infographics for Google Slides and PowerPoint

    Clinical Trial Infographics. Free Google Slides theme, PowerPoint template, and Canva presentation template. These Clinical Trial Infographics are simply great for medical purposes: talking about treatments, steps, and diseases is simple if you use these timelines, arrows, bars and circle charts, banners and text blocks.