Description: The theoretical and practical challenges to be considered in designing and conducting a clinical trial will be presented. Topics to be discussed include the specification of a primary objective, adherence to accepted ethical guidelines, the role of randomization and the means of its implementation, the choice of design strategy and design strengthening features, and the considerations involved in sample size determination and patient recruitment. Detailed analytic issues will be considered in the complementary one-week course that follows. No prerequisite.
