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Abstract Details

Activity Number: 299
Type: Contributed
Date/Time: Tuesday, July 31, 2012 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #306036
Title: Inclusion of Zero-Event Trials in Meta-Analyses
Author(s): Tianyue Zhou*+
Companies: Sanofi
Address: 55 Corporate Drive, Bridgewater, NJ, 08807, United States
Keywords: Meta analysis ; Fixed effects ; Mantel-Haenszel method ; continuity correction

Meta-analysis of side effects has been widely used to combine data with sparse event rate across comparative clinical studies for evaluating drug safety profile. When dealing with rather rare events, a substantial proportion of studies may not have any events of interest. In common practice, meta-analyses on a relative scale (relative risk or odds ratio) remove zero-event studies while meta-analyses using risk difference as the effect measure include such studies. We plan to examine the influence of zero-event trials through simulation and illustrative examples to provide some guideline of when the zero-event studies should be included and help people decide in a specific problem whether it is worth including such studies. Under fixed-effects framework, Mantel-Haenszel method is chosen to pool the odds ratio and weighted average method using Mantel-Haenszel weights is applied to pool the risk difference between treatment groups. Zero-event studies are included in the meta-analysis through continuity correction. The bias and the coverage of the 95% confidence intervals based on different measures including/excluding zero-event studies are under investigation.

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