Adaptive Designs: One Reviewer’s Perspective
*Pablo E. Bonangelino, FDA/CDRH 


Adaptive Designs: One Reviewer’s Perspective. I will first give a reviewer’s perspective on the important operational issue of the study accrual rate in its relation to adaptive designs. I will then discuss the statistical approach of optimal alpha, which is based on considering the total error, that is, both alpha and beta, when arriving at a statistical decision. Two examples will be given. The optimal alpha approach will be seen to potentially have important implications for adaptive designs where the concern is an inflated Type I error rate. I will conclude with possible directions for future research related to this approach.