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.
Design and Interpretation of Clinical Trials
Instructors: Janet Holbrook, PhD, MPH
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There are 6 modules in this course
This week, we explore different types of trial designs, including parallel, crossover, group allocation, factorial, large simple, equivalency, non-inferiority, and adaptive designs.
What's included
5 videos3 readings1 assignment2 discussion prompts
This week we discuss two key design features of randomized clinical trials used to protect against bias, randomization and masking.
What's included
3 videos1 reading1 assignment3 discussion prompts
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.
What's included
4 videos1 reading1 assignment2 discussion prompts
This week focuses on a key issue in the field of clinical trials, the ethics of experimentation in humans.
What's included
2 videos6 readings1 assignment2 discussion prompts
This week, we focus on reporting results of clinical trials in publications. We cover the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
What's included
3 videos3 readings1 assignment2 discussion prompts
This week, we focus on whether RCTs are still the gold standard for evaluating evidence.
What's included
3 videos2 readings1 assignment2 discussion prompts
Instructors
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The University of Sydney
University of Cape Town
Novartis
American Psychological Association
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