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Activity Number:
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334
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Type:
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Contributed
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Date/Time:
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Tuesday, July 31, 2007 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #308772 |
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Title:
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On Treatment Selection in Accelerated Drug Development
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Author(s):
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Ying Wan*+ and Keaven M. Anderson and Cong Chen and Boris Iglewicz
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Companies:
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Temple University and Merck & Co., Inc. and Merck & Co., Inc. and Temple University
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Address:
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Speakman Hall 006-00, Philadelphia, PA, 19122,
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Keywords:
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accelerated test designs ; clinical trial ; interim analysis ; two-stage design
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Abstract:
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We present a method for the design of a clinical trial to combine phase 2 and 3 of clinical development. The method provides a two-stage study design allowing a fixed or data dependent number of treatment arms to be selected for stage 2. An example is given to illustrate the method and to examine advantages of the two-stage flexible design. We study some key questions in finding a good strategy for detecting the best treatment(s) and producing a significant result in consideration of limited resources for drug development. Given a prespecified fixed sample size, practical recommendations are made on: whether to select one arm or multiple arms, whether to expand the number of experimental arms in a trial, and what is the appropriate timing of interim analysis.
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