Adaptive Designs for Clinical Trials

Speaker: James Hung, U.S. Food and Drug Administration

Abstract: In recent years adaptive designs have been used in clinical trials for regulatory applications. There are a wide range of adaptations such as re-estimating sample size, changing targeted patient population, dropping dose(s), or a mixture of some of the adaptations. Literature on statistical analysis methods for adaptive designs and trial logistics issues is rich. In this seminar, I shall share some of my insights and experiences on two types of adaptive designs, adaptive statistical information and adaptive selection.

Disclaimer: This abstract reflects the views of the authors and should not be construed to represent the views or policies of the Food and Drug Administration.