All Times EDT
Keywords: Complex Innovative Designs, Clinical Trials, Bayesian methods, Bayesian Hierarchical Modeling, CID Pilot Program
Complex innovative designs (CID) can potentially reduce cost, shorten cycle time and increase probability of success in drug development so new medicines can be delivered to patients in a more expedited way. PDUFA VI and 21st Century Cures Act provide exciting opportunities for industry to collaborate with regulatory agencies in promoting the use of CID. In this presentation, a case study accepted by the FDA CID pilot program will be described. Experiences and considerations from this case study regarding rationale for the design, innovative design elements, evaluation of trial operating characteristics, trial execution, simulation tools being developed, as well as sponsor-regulatory agency interactions will be discussed.