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Activity Number:
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458
- New Challenges in Subgroup Analyses and Enrichment Designs
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 2, 2017 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #322687
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Title:
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Sample Size Calculation in Confirmatory Subgroup Analyses
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Author(s):
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Dong Xi* and Frank Bretz and Ekkehard Glimm
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Companies:
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Novartis Pharmaceuticals Corporation and Novartis AG and Novartis
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Keywords:
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Subgroup analysis ;
Confirmatory trial ;
Multipicity ;
Sample size ;
Prevalence
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Abstract:
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In confirmatory subgroup analyses, subgroups are pre-specified for testing superior efficacy. The overall study population is usually tested as well to bring the better treatment to more patients. This setting creates opportunities to take into account the correlation between the subgroups and the overall population when calculating the sample size for the confirmatory study. In this talk, we formulate the mean and correlation structure between the subgroups and the overall population. We will show the impact of specified/unspecified prevalence in the sample size calculation.
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Authors who are presenting talks have a * after their name.
