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Activity Number:
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243
- Operational Considerations in Clinical Trials
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Type:
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Contributed
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Date/Time:
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Tuesday, August 9, 2022 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #323506
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Title:
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Sample Size Re-Estimation: Timing, Decision Rule, and Study Power
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Author(s):
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David Li* and Yan Li
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Companies:
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Eisai and Washington University School of Medicine
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Keywords:
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sample size ;
power;
adaptive design;
clinical trial
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Abstract:
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Sample size re-estimation (SSR) is performed to ensure sufficient power if the study drug is promising. The idea is implemented by the promising zone approach. It has been shown that a late SSR is better than a mid-study SSR. This presentation will report our systemic evaluation of SSR timing, SSR decision rule on the impact of the study power. some misconceptions with SSR will be revealed.
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Authors who are presenting talks have a * after their name.
