Abstract Details
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Activity Number:
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591
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 7, 2014 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #311540
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View Presentation
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Title:
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A Simulation Study of Sample Size Re-estimation
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Author(s):
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Mike Smith*+
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Companies:
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Pfizer
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Keywords:
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Sample size re-estimation ;
Simulation ;
Adaptive design
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Abstract:
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Sample size re-estimation (SSR) is one of the most commonly applied methods of adaptive design in clinical trials. This talk will use a simulation study to explore characteristics of blinded versus unblinded SSR, in terms of sample size and power. The impact of the maximum sample size limit in SSR will be explored, and advice given on appropriate maximum limits. Finally, the effect of commonly used modifications (no increase of sample size where interim results are 'unfavorable', and/or use of futility stopping) will be explored to consider the improvements in the efficiency of the trial.
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Authors who are presenting talks have a * after their name.
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