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