Course Schedule and Catalog

Long Title: TOPICS IN CLINICAL TRIALS

Department: Statistics

Grade Mode: Standard Letter

Course Type: Lecture

Credit Hours: 3

Prerequisite(s): STAT 410 AND STAT 431

Description: This course deals with fundamental concepts in the design of clinical studies, ranging from early dose-finding studies (phase I) to screening studies (phase II) to randomized comparative studies (phase III). The goal is to prepare the student to read the clinical trial literature critically and to design clinical studies. Additionally, the faculty will introduce newer designs for clinical studies that incorporate prior knowledge and/or satisfy optimality considerations. Topics include protocol writing; randomization; sample size calculation; study design options; interim monitoring; adaptive designs; multiple end points; and writing up the results of a clinical trial for publication.