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Activity Number:
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273
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, July 31, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #310072 |
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Title:
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Statistical Analysis for Two-Stage Adaptive Design with Different Study Endpoints
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Author(s):
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Shein-Chung Chow*+ and Siu-Keung Tse
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Companies:
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Duke University and Hong Kong City University
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Address:
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School of Medicine, 2400 Pratt Street, Durham, NC, 27705,
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Keywords:
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Biomarker ; Two-stage adaptive design ; Sample size calculation ; Different study endpoints
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Abstract:
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In the pharmaceutical industry, it is desirable to apply an adaptive seamless trial design to combine two separate clinical studies that are normally conducted for achieving separate objectives such as a phase II study for dose finding and a phase III confirmatory study for efficacy. In some cases, however, the study endpoints for the two separate studies may be different due to long treatment duration. In this case, test statistics for the final analysis based on the combined data are necessary developed. In this paper, a test statistic utilizing data collected from both phases is proposed assuming that there is a well established relationship between the two different study endpoints. Formula for sample size calculation based on the proposed test statistic is derived. Sample size allocation at the two phases is also discussed.
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