ABSTRACT

Until now we have been considering how to maximize the efficiency of drug development through the optimization of the size and type 1 error of Phase 2 trials. As we mentioned at the beginning of this book, sizing a trial in one phase of drug development and then deciding whether to go on to the next phase is an issue that permeates all of drug development. In this section we adapt the approach developed for evaluating the Phase 2/3 decision problem to address the optimization of multiple screening trials that precede a definitive trial.