Clinical Trials

This course is to serve as a general introduction to clinical trials and will emphasize trial design issues. This is not a course on the biostatistics of clinical trials. It is expected that at the conclusion of the course, a student will be able to plan a clinical trial. Each class will consist of a two-hour lecture followed by a one-hour discussion. The weekly session will focus on either a group discussion of the assigned reading or a practical application based on the material presented during the two-hour lecture. Students will be evaluated on their participation in class (20%); a clinical trial document (50%), which should include the rationale for the study, study design, objectives and endpoints, sample size and analysis sections, and consent form; and a class presentation of their trial or another topic (30%).