Simulations in Forecasting Recruitment, Drug Supply, Event Occurrence, and Efficiency of Drug Development

• Activity Number: 386
• Type: Topic Contributed
• Date/Time: Tuesday, July 31, 2012 : 2:00 PM to 3:50 PM
• Sponsor: Committee on Applied Statisticians
• Author(s): James Bolognese*+ and Nitin Patel
• Companies: Cytel Inc. and Cytel Inc.
• Keywords: modeling and simulation ; adaptive design ; program optimization ; portfolio optimization ; drug supply ; patient recruitment

Abstract

Recent increased compute power facilitates modeling and simulation (M&S) to improve efficiency of drug development, including trial design, drug program design, and research budget allocation. For trial design, M&S have facilitated use of adaptive designs, which can improve performance criteria over those of non-adaptive designs. Adaptive design execution can be improved by M&S to optimize drug supply and forecast patient recruitment. Composition of study sequence of individual drug development programs can be optimized via M&S. Once each drug development program in portfolio is optimized, M&S can optimally allocate a research budget to maximize net present value of that entire portfolio. Obviously, research management would not rely only on M&S for decision-making; rather, M&S is a useful addition to the tool chest supporting such decisions. This talk gives examples of cases and software for: (1) adaptive clinical trial design (2) forecasting drug supply for adaptive designs (3) forecasting patient recruitment and event rates (4) optimizing Ph2/3 drug development program design (adaptive & non-adaptive) (5) research budget optimization across a portfolio of drug programs