Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods

1.4 Emergence of Adaptive Designs in the 90s

Sequential and group sequential designs are a special kind of adaptive designs. While group sequential designs originated in the 60s, one can probably credit Bauer’s work as the origin of what some refer to today as adaptive design [38]. Bauer first described sample size adaptation based on results of an unblinded interim analysis [38]. Bauer and coauthors gave a historical overview of the history of confirmatory adaptive designs over the 25 years since 1989 [39]. They describe the early days of adaptive design research, review the key methodological concepts, and summarize regulatory and industry perspectives on adaptive designs. The overview includes an extensive list of references (178 of them) ...