ABSTRACT
In the previous chapter, we constructed an admissible class of Phase 2 trial designs and decision rules to help guide the design of Phase 2 trials and the associated decision making. In this section we consider another approach to designing the Phase 2/3 clinical development program for a new drug which is to maximize the minimum efficiency. That is, taking the magnitude of the treatment effect as uncertain, one could proceed to design the Phase 2 trial in such a way as to minimize the impact on efficiency if the magnitude of the treatment effect turns out to be the worst case for efficiency.
