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Activity Number:
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430
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Type:
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Contributed
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Date/Time:
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Wednesday, August 5, 2009 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304281 |
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Title:
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Evaluating the Efficiencies of Adaptive Design Trials - Case Studies Based on Real Clinical Trial Data
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Author(s):
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Suvajit Samanta*+ and Weili He
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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 E. Lincoln Ave., Rahway, NJ, 07065,
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Keywords:
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Adaptive design ; clinical trials ; drug supply strategy ; simulation methodology ; nonparametric bootstrap ; Seamless Phase II/III
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Abstract:
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In literature little information has been presented on case studies of adaptive design scenarios and the potential gains in efficiency as compared to traditional trials. Simulations play an important role in assessing the performance of adaptive designs as it is often too complex to determine operating characteristics of adaptive designs. The simulation studies make assumptions including treatment response curve, distribution of responses which are generally unknown at the beginning of clinical development program or trial. This research assesses the performance of a few adaptive design scenarios by simulating adaptive design scenarios based on data from completed real clinical trials using permutation method or nonparametric bootstrap method. The proposed assessment is robust as it does not make any underlying assumptions with regard to the correlations of the endpoints or time points.
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