ABSTRACT
Until this point, we have focused primarily on maximizing the efficiency of a clinical development program that is comprised of a Phase 2 screening trial followed by an 80 percent powered Phase 3 trial with a single analysis at completion. In this chapter we extend the model of clinical development in three ways. First, we look at the model from the point of view of maximizing net present value (NPV) when the project is part of a portfolio of other projects. Second, we consider a model of clinical development where the Phase 2 trial is designed to pick the better of two doses to go forward to Phase 3 and the Phase 3 trial includes an interim analysis. And finally, we consider a model of drug development for studying new molecules that may have enhanced activity in a subpopulation with high expression of a specific marker.
