JSM 2011 Online Program

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Abstract Details

Activity Number: 565
Type: Topic Contributed
Date/Time: Wednesday, August 3, 2011 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #301355
Title: Assessment of Safety Performance Goal Related to Rare-Event Meta-Analysis in Medical Device Studies
Author(s): Hsini Terry Liao*+
Companies: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, MA, 01752-1234,
Keywords: meta-analysis ; rare event ; sample size justification ; performance goal ; medical device

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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