CCTR 631. Adaptive Clinical Trials. 1 Hour.

Semester course; 1 lecture hour. 1 credit. Prerequisite: CCTR 630 or BIOS 571. This course is intended for the research scientist who is interested in advancing innovative trial designs and wishing to incorporate adaptations, modifications and changes to the clinical trial process. The goal is to enhance comprehension and methodologic skills in designing adaptive clinical trials for clinical investigators. The course provides an overview of the theoretical framework and key concepts of adaptive design methods in clinical trials. The design and implementation process are discussed through real-world examples. The feasibility, validity, integrity and efficiency of the trial designs will be stressed through comparisons between traditional fixed and adaptive trials. Graded as pass/fail.