Design and Interpretation of Clinical Trials

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Design and Interpretation of Clinical Trials

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About this course: Clinical trials are experiments designed to evaluate new interventions to prevent or treat disease in humans. The interventions evaluated can be drugs, devices (e.g., hearing aid), surgeries, behavioral interventions (e.g., smoking cessation program), community health programs (e.g. cancer screening programs) or health delivery systems (e.g., special care units for hospital admissions). We consider clinical trials experiments because the investigators rather than the patients or their doctors select the treatment the patients receive. Results from randomized clinical trials are usually considered the highest level of evidence for determining whether a treatment is eff…

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Didn't find what you were looking for? See also: Interpreting, Two Dimensional Design (2D Design), Translation, Phonetics, and Pharmaceutical.

When you enroll for courses through Coursera you get to choose for a paid plan or for a free plan

  • Free plan: No certicification and/or audit only. You will have access to all course materials except graded items.
  • Paid plan: Commit to earning a Certificate—it's a trusted, shareable way to showcase your new skills.

About this course: Clinical trials are experiments designed to evaluate new interventions to prevent or treat disease in humans. The interventions evaluated can be drugs, devices (e.g., hearing aid), surgeries, behavioral interventions (e.g., smoking cessation program), community health programs (e.g. cancer screening programs) or health delivery systems (e.g., special care units for hospital admissions). We consider clinical trials experiments because the investigators rather than the patients or their doctors select the treatment the patients receive. Results from randomized clinical trials are usually considered the highest level of evidence for determining whether a treatment is effective because trials incorporates features to ensure that evaluation of the benefits and risks of treatments are objective and unbiased. The FDA requires that drugs or biologics (e.g., vaccines) are shown to be effective in clinical trials before they can be sold in the US. The course will explain the basic principles for design of randomized clinical trials and how they should be reported. In the first part of the course, students will be introduced to terminology used in clinical trials and the several common designs used for clinical trials, such as parallel and cross-over designs. We will also explain some of the mechanics of clinical trials, like randomization and blinding of treatment. In the second half of the course, we will explain how clinical trials are analyzed and interpreted. Finally, we will review the essential ethical consideration involved in conducting experiments on people.

Created by:  Johns Hopkins University
  • Taught by:  Janet Holbrook, PhD, MPH, Associate Professor, Epidemiology

    Bloomberg School of Public Health
  • Taught by:  Lea T. Drye, PhD, Assistant Scientist, Epidemiology

    Bloomberg School of Public Health
Language English How To Pass Pass all graded assignments to complete the course. User Ratings 4.7 stars Average User Rating 4.7See what learners said Coursework

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Johns Hopkins University The mission of The Johns Hopkins University is to educate its students and cultivate their capacity for life-long learning, to foster independent and original research, and to bring the benefits of discovery to the world.

Syllabus


WEEK 1


Types of Trial Designs
This week, we explore different types of trial designs, including parallel, crossover, group allocation, factorial, large simple, equivalency, non-inferiority, and adaptive designs.


5 videos, 3 readings expand


  1. Video: Welcome Video
  2. Reading: Welcome Message
  3. Reading: Syllabus
  4. Reading: Pre-Course Survey
  5. Video: Lecture 1A: Comparison Structure: Parallel, Crossover, and Group Allocation Designs
  6. Video: Lecture 1B: Extensions of the Parallel Design: Factorial and Large Simple Designs
  7. Video: Lecture 1C: Testing for Hypotheses Other than Superiority: Equivalency and Non-Inferiority Designs
  8. Video: Lecture 1D: Adaptive Design
  9. Discussion Prompt: Examples of clinical trials that you know about
  10. Discussion Prompt: Why did they choose that design?

Graded: Quiz 1

WEEK 2


Randomization and Masking
This week we discuss two key design features of randomized clinical trials used to protect against bias, randomization and masking.


3 videos, 1 reading expand


  1. Reading: Welcome to Week 2
  2. Video: Lecture 2A: Rationale for Randomization
  3. Video: Lecture 2B: Types of Schemes
  4. Video: Lecture 3: Masking
  5. Discussion Prompt: Why is flipping a coin a bad randomization scheme?
  6. Discussion Prompt: Analyze a treatment assignment list
  7. Discussion Prompt: Simple, Restrictive, or Adaptive

Graded: Quiz 2

WEEK 3


Outcomes and Analysis
This week focuses on a key design issue - selecting the primary outcome. We will also cover the gold standard for analysis of clinical trials, which is including all the participants in the analysis regardless of their actual treatment.


4 videos, 1 reading expand


  1. Reading: Welcome to Week 3
  2. Video: Lecture 4A: Outcomes: Definitions & Types
  3. Video: Lecture 4B: Influence on Design
  4. Video: Lecture 5A: Analysis by Assigned Treatment (Intention to Treat)
  5. Video: Lecture 5B: Subgroup Analysis
  6. Discussion Prompt: Tell us about outcomes in clinical trials you know about
  7. Discussion Prompt: Chat about how adherence is measured in clinical trials

Graded: Quiz 3

WEEK 4


Ethics
This week focuses on a key issue in the field of clinical trials, the ethics of experimentation in humans.


2 videos, 6 readings expand


  1. Reading: Welcome to Week 4
  2. Video: Lecture 6A: Equipoise, IRBs, and HIPAA
  3. Video: Lecture 6B: Contemporary Ethical Issues
  4. Reading: The Belmont Report
  5. Reading: Common Rule 45CFR46
  6. Reading: Declaration of Helsinki
  7. Reading: HIPAA Privacy Rule Booklet
  8. Reading: The Nuremberg Code
  9. Discussion Prompt: What are the advantages of using a placebo versus an active control?
  10. Discussion Prompt: Access to experimental treatments - in the news

Graded: Quiz 4

WEEK 5


Reporting Results
This week, we focus on reporting results of clinical trials in publications. We cover the Consolidated Standards of Reporting Trials (CONSORT) guidelines.


3 videos, 3 readings expand


  1. Reading: Welcome to Week 5
  2. Video: Lecture 7A: Reporting Results from Trials
  3. Video: Lecture 7B: CONSORT Guidelines
  4. Video: Lecture 7C: Evaluating Literature
  5. Reading: Reporting of noninferiority and equivalence randomized trials
  6. Reading: The CONSORT Statement
  7. Discussion Prompt: Your experience with incomplete trial reporting
  8. Discussion Prompt: Bias in writing and publishing trials

Graded: Quiz 5

WEEK 6


Randomized Clinical Trials
This week, we focus on whether RCTs are still the gold standard for evaluating evidence.


3 videos, 2 readings expand


  1. Reading: Welcome to Week 6
  2. Video: Lecture 8A: Are Randomized Clinical Trials Still the Gold Standard?
  3. Video: Lecture 8B: High-Profile Cases
  4. Discussion Prompt: Inconsistent findings
  5. Discussion Prompt: Observational studies
  6. Video: Wrap-Up Video
  7. Reading: Post Course Survey

Graded: Quiz 6
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