Joint Optimization of Phase II and Phase III Designs When One or Two Doses Can Be Carried into Phase III

• Activity Number: 479
• Type: Topic Contributed
• Date/Time: Wednesday, August 12, 2015 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Nitin Patel* and James Bolognese and Jaydeep Bhattacharyya
• Companies: Cytel Inc. and Cytel Inc. and Cytel Inc.
• Keywords: Program Optimization ; Phase 2 ; Phase 3 ; Clinical trials ; Neuropathic Pain ; More than one dose

Abstract

In past work we have shown the value of program level optimization of Phase 2 and Phase 3 clinical trial designs for neuropathic pain (Patel N et.al. 'Designing Phase 2 Trials Based on Program-Level Considerations: A Case Study for Neuropathic Pain', Drug Information Journal, 2012, 46 (4) 439-454). The objective in that publication was to maximize Expected Net Present Value (ENPV) of the program while taking into account both efficacy and safety considerations. In this talk we will discuss extensions of that work to carrying two doses into Phase 3 when Phase 2 results indicate sufficient separation in efficacy between them in addition to meeting efficacy and safety targets. We consider situations where results may require additional Phase 3 programs for regulatory approval to enable taking two doses to market. In addition to the objective of maximizing ENPV we examine optimization with the objective of maximizing clinical utility.