This course is to serve as a general introduction to clinical trials. This course 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 on a practical application based on the material presented during the two-hour lecture.