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Design and Interpretation of Clinical Trials
  • Level Foundation
  • Duration 10 hours
  • Course by Johns Hopkins University
  • Offered by

About

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.

Modules

Welcome to Design and Interpretation of Clinical Trials

    • 1 Videos
    • 3 Readings
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1 Videos

  • Welcome Video

3 Readings

  • Welcome Message
  • Syllabus
  • Pre-Course Survey

Types of Trial Designs

    • 4 Videos
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4 Videos

  • Lecture 1A: Comparison Structure: Parallel, Crossover, and Group Allocation Designs
  • Lecture 1B: Extensions of the Parallel Design: Factorial and Large Simple Designs
  • Lecture 1C: Testing for Hypotheses Other than Superiority: Equivalency and Non-Inferiority Designs
  • Lecture 1D: Adaptive Design

Up For Discussion

    • 2 Discussion
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2 Discussions

  • Examples of clinical trials that you know about
  • Why did they choose that design?

Graded Assignment

    • 1 Assignment
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1 Assignment

  • Quiz 1

Randomization and Masking

    • 1 Readings
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1 Readings

  • Welcome to Week 2

Randomization

    • 2 Videos
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2 Videos

  • Lecture 2A: Rationale for Randomization
  • Lecture 2B: Types of Schemes

Masking

    • 1 Videos
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1 Videos

  • Lecture 3: Masking

Up For Discussion

    • 3 Discussion
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3 Discussions

  • Why is flipping a coin a bad randomization scheme?
  • Analyze a treatment assignment list
  • Simple, Restrictive, or Adaptive

Graded Assignment

    • 1 Assignment
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1 Assignment

  • Quiz 2

Outcomes and Analysis

    • 1 Readings
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1 Readings

  • Welcome to Week 3

Outcomes

    • 2 Videos
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2 Videos

  • Lecture 4A: Outcomes: Definitions & Types
  • Lecture 4B: Influence on Design

Analysis Issues in Clinical Trials

    • 2 Videos
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2 Videos

  • Lecture 5A: Analysis by Assigned Treatment (Intention to Treat)
  • Lecture 5B: Subgroup Analysis

Up For Discussion

    • 2 Discussion
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2 Discussions

  • Tell us about outcomes in clinical trials you know about
  • Chat about how adherence is measured in clinical trials

Graded Assignment

    • 1 Assignment
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1 Assignment

  • Quiz 3

Ethics

    • 1 Readings
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1 Readings

  • Welcome to Week 4

Ethical Issues in Clinical Trials

    • 2 Videos
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2 Videos

  • Lecture 6A: Equipoise, IRBs, and HIPAA
  • Lecture 6B: Contemporary Ethical Issues

Important Readings in the Ethics of Human Subjects Research

    • 5 Readings
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5 Readings

  • The Belmont Report
  • Common Rule 45CFR46
  • Declaration of Helsinki
  • HIPAA Privacy Rule Booklet
  • The Nuremberg Code

Up For Discussion

    • 2 Discussion
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2 Discussions

  • What are the advantages of using a placebo versus an active control?
  • Access to experimental treatments - in the news

Graded Assignment

    • 1 Assignment
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1 Assignment

  • Quiz 4

Reporting Results

    • 1 Readings
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1 Readings

  • Welcome to Week 5

Clinical Trials Literature Standards and Critical Reading

    • 3 Videos
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3 Videos

  • Lecture 7A: Reporting Results from Trials
  • Lecture 7B: CONSORT Guidelines
  • Lecture 7C: Evaluating Literature

CONSORT Readings

    • 2 Readings
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2 Readings

  • Reporting of noninferiority and equivalence randomized trials
  • The CONSORT Statement

Up For Discussion

    • 2 Discussion
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2 Discussions

  • Your experience with incomplete trial reporting
  • Bias in writing and publishing trials

Graded Assignment

    • 1 Assignment
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1 Assignment

  • Quiz 5

Randomized Clinical Trials

    • 1 Readings
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1 Readings

  • Welcome to Week 6

Are Randomized Clinical Trials Still The Gold Standard?

    • 2 Videos
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2 Videos

  • Lecture 8A: Are Randomized Clinical Trials Still the Gold Standard?
  • Lecture 8B: High-Profile Cases

Up For Discussion

    • 2 Discussion
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2 Discussions

  • Inconsistent findings
  • Observational studies

Graded Assignment

    • 1 Assignment
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1 Assignment

  • Quiz 6

Wrap-Up

    • 1 Videos
    • 1 Readings
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1 Videos

  • Wrap-Up Video

1 Readings

  • Post Course Survey

Auto Summary

Discover the essential principles of designing and interpreting randomized clinical trials in this foundational course from Coursera. Spanning 600 minutes, it covers trial terminology, design types, randomization, blinding, analysis, interpretation, and ethical considerations. Led by expert instructors, it's ideal for those in science and engineering fields. Choose from Starter, Professional, or Paid subscription options to get started.

Janet Holbrook, PhD, MPH
Instructors

Janet Holbrook, PhD, MPH

Lea T. Drye, PhD
Instructors

Lea T. Drye, PhD