Analysis of Two-Stage Adaptive Trial Designs

Abstract

In the past decade, adaptive design methods in clinical research have attracted much attention because it offers not only the principal investigators potential flexibility for identifying clinical benefit of a test treatment under investigation, but also efficiency for speeding up the development process. The FDA adaptive design draft guidance defines an adaptive design as a clinical study that includes a prospectively planned opportunity for modification of one or more specified aspects of the study design and hypotheses based on analysis of data (usually interim data) from subjects in the study.