Lecture, three hours; discussion, two hours. Requisites: courses 100A, 100B. Design of studies in animals to assess antitumor response; randomization, historical controls, p-values, size of study, and stratification in human experimentation; various types of controls; prognostic factors, survivorship studies, and design of prognostic studies; organization of clinical trials--administration, comparability, protocols, clinical standards, data collection and management. S/U (optional only for nonmajors) or letter grading.