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Abstract Details
Activity Number:
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167
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Type:
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Topic Contributed
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Date/Time:
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Monday, July 30, 2012 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #305189 |
Title:
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Time-to-Event Meta-Analysis for Rare Safety Outcomes
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Author(s):
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Xiao Ding*+ and Mat Soukup and Bradley McEvoy
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Companies:
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Gilead Sciences and FDA/CDER and FDA/CDER
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Address:
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, Silver Spring, MD, , USA
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Keywords:
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meta-analysis ;
time to event ;
Cox regression ;
log rank test ;
rare outcome ;
safety analysis
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Abstract:
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Recent research has shown that similar results should be expected from three popular methods for time-to-event meta-analysis: stratified Cox regression, stratified log-rank, and Inverse-variance weighted Cox model. In the regulatory setting, meta-analysis approach is needed for safety evaluation when the outcome is somewhat rare (incidence rate often no more than 1%~2% per year). We found that the results from the three methods might differ dramatically for rare outcome. We also explore other alternatives to improve the performance of time-to-event such as the use of penalized MLE (Firth's procedure) and the use of sample size weighting to replace inverse-variance weighting. Statistical properties, including power, type 1 error rate, bias of the point estimate, and coverage of the confidence interval, are compared among all the methods. Under different setting, different method is recommended.
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