Abstract Details
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Activity Number:
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302
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, August 6, 2013 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309058 |
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Title:
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Confirmatory Subgroup Analysis: Multiple Testing Approaches
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Author(s):
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Alexei Dmitrienko*+
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Companies:
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Quintiles
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Keywords:
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Subgroup analysis ;
Multiplicity ;
Type I error rate
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Abstract:
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This talk will focus on a broad class of multiplicity problems arising in the context of confirmatory subgroup analysis, i.e., analysis of Phase III clinical trials designed to pursue tailoring objectives. The objectives include evaluation of treatment effects in one or more target subpopulations (defined by demographics, clinical or genetic markers) in addition to standard analyses in the overall patient population. A review and comparison of multiplicity adjustment methods used in confirmatory subgroup analysis will be provided, including non-parametric and parametric procedures, and gatekeeping procedures used in the analysis of "multi-dimensional" multiplicity problems involving pre-specified subgroups.
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Authors who are presenting talks have a * after their name.
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