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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 - #306227
Title: Comparison of Meta-Analysis Methods for Clinical Trials with Rare Events: A Case Study
Author(s): Li Wei*+ and Lisa Ying and David Henry
Companies: Bristol-Myers Squibb and Bristol-Myers Squibb and Bristol-Myers Squibb
Address: 311 Pennington-Rocky Hill Road, Pennington, NJ, 08534, United States
Keywords: Meta-analysis ; Relative risk ; Relative difference ; Rare events

As a statistical technique to combine information across various data sources to improve precision of results, meta-analysis has been widely utilized in clinical projects which consist of multiple studies. Relative risk (RR) or risk difference (RD) are of major interests in many clinical trials. Multiple statistical procedures for analysis of RR and RD have been available in literature. However, most of them have some limitations and may lead to totally different conclusions, especially in the situation of rare events. We examined the advantages and weakness of those methods, conventional or proposed recently, approximate or exact, and then applied to a real clinical project including 19 phase 2/3 clinical studies.

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