Abstract Details
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Activity Number:
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634
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 8, 2013 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #308818 |
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Title:
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Sample Size Re-Estimation in Confirmatory Studies
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Author(s):
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Min Lin*+
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Companies:
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Keywords:
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Sample Size Re-estimation ;
Adaptive Design
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Abstract:
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Sample size re-estimation (SSR) is a commonly seen adaptive design feature in confirmatory clinical trials. The need for SSR at interim is mainly due to the uncertainty of parameter estimate (e.g. variability for the primary endpoint) used during the planning stage of the study. SSR may be conducted in a blinded or an unblinded fashion on the basis of different criteria, such as effect size or conditional power. In this talk, various SSR approaches will be examined in terms of overall type I error rate, bias in the point estimates and unconditional power. All results are based on sufficient mathematical justifications. Simulation studies will also be presented to support the discussion.
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Authors who are presenting talks have a * after their name.
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