Design and Interpretation of Clinical Trials

Learn the basic principles for design of randomized clinical trials and how they should be reported.

About The 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 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.

Frequently Asked Questions

Will I get a Statement of Accomplishment after completing this class?
Yes. Students who earn a sufficient final grade will receive a Statement of Accomplishment signed by the instructor.

Will I get clinical advice in this course?
No. This course deals with principles of public health and the design of trials, not individual clinical situations.

Recommended Background

Student should have an interest in health sciences.  Some fundamental knowledge of epidemiology, e.g., types of bias, and statistics, e.g., mean and standard deviation, hypothesis testing, will be helpful.