Meta-Analysis for Rare Adverse Event Data from Clinical Trials

• Activity Number: 330
• Type: Topic Contributed
• Date/Time: Tuesday, August 3, 2010 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Brenda Crowe*+
• Companies: Eli Lilly and Company
• Keywords: meta-analysis ; safety ; harms ; rare adverse events

Abstract

An integral part of the development of a drug is the assessment of adverse events through the evaluation of multiple clinical trials via meta-analysis. There are a variety of effect measures that can be used in the analysis, for example, risk difference, risk ratio and odds ratio. Rare adverse events are particularly problematic as there is a high chance of zero events in some treatment groups or entire studies. For trials with no events, neither the risk ratio nor the odds ratio is defined. In this presentation I will discuss various statistical aspects of meta-analysis for rare adverse events. These include choice of effect measure, continuity correction and analytical method, including a discussion of fixed vs. random effects, existing methods and new advances. A direct application is the assessment of cardiovascular risk in antidiabetic medications.