ABSTRACT
Multiple endpoints are common in clinical trials. In this chapter, we …rst discuss the multiple endpoint issues and commonly used methods in classic designs. We will review the single-stage and stepwise methods. The gatekeeper method is particularly interesting; we will extend this method to multiple-endpoint adaptive trials to develop the “fractal gatekeeper” method. A trial example will be used to illustrate step by step how to use the fractal gatekeeper method for analyzing multiple-endpoint adaptive trials.
