DAE

Abstract

We consider the joint design of Phase II and Phase III trials. We propose a decision theoretic formulation with a gain function arising from a positive Phase III outcome and costs for sampling and for time taken to reach a positive conclusion. With a prior for the dose response model and a risk curve for the probability that doses fail on safety grounds, the challenge is to optimise the design for comparing doses in Phase II, the choice of dose or doses to take forward to Phase III, and the Phase III design. We shall show it is computationally feasible to tackle this problem and discuss possible generalisations from an initial, simple formulation.