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Abstract Details
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Activity Number:
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565
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 3, 2011 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301355 |
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Title:
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Assessment of Safety Performance Goal Related to Rare-Event Meta-Analysis in Medical Device Studies
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Author(s):
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Hsini Terry Liao*+
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Companies:
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Boston Scientific Corporation
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Address:
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100 Boston Scientific Way, Marlborough, MA, 01752-1234,
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Keywords:
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meta-analysis ;
rare event ;
sample size justification ;
performance goal ;
medical device
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Abstract:
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The study-level meta-analysis is sometimes involved in the sample size justification in terms of non-inferiority margin to performance goal in a single-arm study or to treatment effect in a two-arm clinical trial. In meta-analysis, there are challenges when at least one of the following quantities is small: sample sizes from individual studies, total number of studies and total number of events. Due to frequent innovations for specific indications in medical device world, low patient enrollment, lack of publications, and rare events have often been aware during study designing phase. Without loss of generality, assessment of the focus is on sensitivity of the performance goal in a single-arm study with those challenges being incorporated.
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Authors who are presenting talks have a * after their name.
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