Optimizing adaptive design for Phase 2 dose-finding trials incorporating long-term success and financial considerations: A case study for neuropathic pain

Abstract In this paper, we propose an adaptive randomization design for Phase 2 dose-finding trials to optimize Net Present Value(NPV) for an experimental drug. We replace the traditional fixed sample size design (Patel, et al., 2012) by this new designto see if NPV from the original paper can be improved. Comparison of the proposed design to the previous design is made via simulations using a hypothetical example based on a Diabetic Neuropathic PainStudy.