Abstract Details
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Activity Number:
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486
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Type:
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Contributed
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Date/Time:
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Wednesday, August 7, 2013 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309903 |
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Title:
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Testing Key Secondary Claims in Adaptive Design Settings
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Author(s):
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George Kordzakhia*+ and Eiji Ishida and John Lawrence
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Companies:
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Food & Drug Administration and FDA and FDA
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Keywords:
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multiple testing ;
adaptive design ;
interim analysis
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Abstract:
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In this talk we consider adaptive design settings with possibility of dropping treatment arms based on unblinded interim analysis of the primary endpoint. Mutiple testing problems with logical relationship among the hypotheses are discussed. We give examples of the cases where type I error is inflated in the presence of the key secondary claims and propose testing approaches that provide strong control of type I error and accomodate for logical relationships.
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Authors who are presenting talks have a * after their name.
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