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Activity Number:
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79
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Type:
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Contributed
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Date/Time:
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Sunday, August 2, 2009 : 4:00 PM to 5:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304286 |
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Title:
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Extended Fallback Procedures with Clinical Trial Applications
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Author(s):
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Yan D. Zhao*+ and Alexei A. Dmitrienko and Brian L. Wiens
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Companies:
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Eli Lilly and Company and Eli Lilly and Company and Gilead Sciences, Inc.
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Address:
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Lilly Corporate Centers, Indianapolis, IN, 46285,
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Keywords:
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multiple testing ; fallback procedure ; clinical trials ; multiple endpoints
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Abstract:
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This talk discusses a family of multiple testing procedures (known as extended fallback procedures) for testing problems with ordered hypotheses. Examples include clinical trials with multiple endpoints or multiple subgroup analyses. Procedures in this family account for the hierarchical structure of the problem by testing the hypotheses sequentially. Further, the significance level used for the first hypothesis is prespecified and the levels for the other hypotheses are determined by the significance of tests carried out earlier in the sequence as well as the magnitude of the associated p-values (e.g., the smaller the p-value for the first hypothesis, the higher the significance level for the second hypothesis). Performance of different extended fallback procedures is assessed via simulations and the methodology is illustrated using clinical trials with multiple endpoints.
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