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Abstract Details
Activity Number:
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386
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, July 31, 2012 : 2:00 PM to 3:50 PM
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Sponsor:
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Committee on Applied Statisticians
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Abstract - #304197 |
Title:
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Simulations in Forecasting Recruitment, Drug Supply, Event Occurrence, and Efficiency of Drug Development
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Author(s):
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James Bolognese*+ and Nitin Patel
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Companies:
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Cytel Inc. and Cytel Inc.
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Address:
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64 High Street, Woodbridge, NJ, 07095, United States
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Keywords:
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modeling and simulation ;
adaptive design ;
program optimization ;
portfolio optimization ;
drug supply ;
patient recruitment
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Abstract:
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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
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Authors who are presenting talks have a * after their name.
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