Theoretical Basis of Adaptive Designs for Clinical Trials in Phase II and III

Abstract

Adaptive design is one of the most active research areas in clinical statistics for the last decade. This paper will give an introduction to the theory of two stage adaptive designs based on the pioneering articles by Bauer and Kohne (1994) and Proschan and Hunsberger (1995). As an application of Bauer and Kohne method, Bauer and Kiser method for two stage adaptive dose selection procedure in a dose response study is illustrated. Two actual examples of a confirmatory two treatments trial and a dose response study are briefly given.