ABSTRACT
This chapter presents industry benchmarks in clinical development. It discusses the optimization of clinical development programs using stochastic decision process (SDP) and the framework of clinical development program optimization (CDPO). The chapter also discusses how to construct a SDP, from a stochastic process, for the clinical development program by adding action options to each of the action points and the associated gain in terms of net present value (NPV) when each milestone is achieved. CDPO is different from a single trial optimization (STO), STO is a local optimization, whereas CDPO is global optimization. The SDP model of NPV will be used to evaluate the efficiency of a clinical development program, while recognizing the different success rate for different trial designs and clinical development programs. Clinical trial simulation is a useful tool for adaptive designs and CDP optimization.
