JSM 2012 Home

JSM 2012 Online Program

The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.

Online Program Home

Abstract Details

Activity Number: 167
Type: Topic Contributed
Date/Time: Monday, July 30, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305189
Title: Time-to-Event Meta-Analysis for Rare Safety Outcomes
Author(s): Xiao Ding*+ and Mat Soukup and Bradley McEvoy
Companies: Gilead Sciences and FDA/CDER and FDA/CDER
Address: , Silver Spring, MD, , USA
Keywords: meta-analysis ; time to event ; Cox regression ; log rank test ; rare outcome ; safety analysis

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.

The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.

Back to the full JSM 2012 program

2012 JSM Online Program Home

For information, contact jsm@amstat.org or phone (888) 231-3473.

If you have questions about the Continuing Education program, please contact the Education Department.