STAT 630 - TOPICS IN CLINICAL TRIALS
Long Title: TOPICS IN CLINICAL TRIALS
Grade Mode: Standard Letter
Course Type: Lecture
Credit Hours: 3
Must be enrolled in one of the following Level(s):
Prerequisite(s): STAT 519 AND STAT 615
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.