Optimizing Adaptive Design for Phase II Dose-Finding Trials Incorporating Long-Term Success and Financial Considerations

• Activity Number: 479
• Type: Topic Contributed
• Date/Time: Wednesday, August 12, 2015 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Narinder Nangia* and Jingjing Gao and James Bolognese and Jaydeep Bhattacharyya and Nitin Patel
• Companies: AbbVie and AbbVie and Cytel Inc. and Cytel Inc. and Cytel Inc.
• Keywords: adaptive design ; Net Present Value ; phase 2 dose finding trials ; probability of success

Abstract

The accelerated use of adaptive design in clinical trials has provided drug research and development a more flexible and effective approach to better distribute resources and fitting patients' needs. Nevertheless, the extensive adaptive design research mainly focuses on the logistics of the trial itself lacking the global view which should incorporate both drug innovation and finance considerations. In this paper, we compare the adaptive design to the traditional fixed sample size design for phase 2 dose finding trials to optimize Net Present Value (NPV) for a drug via simulations of a single Phase 2 trial followed by 2 phase 3 trials. Results demonstrate that the adaptive design not only requires smaller sample size with higher probability of success in a phase 3 study, but also produces higher expected NPV than the fixed design in the long run.