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Abstract Details
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Activity Number:
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517
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Type:
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Contributed
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Date/Time:
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Wednesday, August 3, 2011 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301922 |
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Title:
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Considerations on Decision Rules for Futility Based on Multiple Studies
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Author(s):
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Annpey Pong*+ and Jun Zhao
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Companies:
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Merck & Co., Inc. and Merck & Co., Inc.
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Address:
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126 East Lincoln Avenue, Rahway, NJ, 07065,
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Keywords:
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Interim analysis ;
possibility of success ;
futility ;
program-wise futility
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Abstract:
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In drug research and development, interim analyses may be applied to evaluate the possibility of success in order to stop a trial early for futility. According to literature, the futility decision (GO/NOGO) is mostly applied to an individual clinical trial. However, to reduce the lengthy drug development, it is common to have multiple ongoing studies in a development program at the same time for a new indication; and it is also common to have failed or negative studies in the program. The goal of the futility analysis is then extended to make GO or NOGO decision on whether to continue developing the entire program. In this presentation, the decision rules based on various considerations on multiple studies are proposed. In addition, example is given from a central nervous system drug development program.
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