Keywords: meta-analysis, safety, FDA
Meta-analyses of randomized clinical trials are commonly used to evaluate the risk of rare adverse events that are difficult to study in an individual trial. However, meta-analyses also present challenges resulting from the integration of heterogeneous trials. The FDA guidance on meta-analyses of randomized controlled clinical trials describes basic principles and recommendations to consider when conducting a meta-analysis. In this talk, we will discuss some of the recommendations described in the guidance. We will also briefly discuss lessons learned from a retrospective meta-analysis to evaluate the risk of neuropsychiatric adverse events associated with varenicline conducted by Pfizer and submitted to the FDA in 2014, and a prospective meta-analysis to evaluate the risk of serious asthma-related adverse events associated with the use of Long-Acting Beta-Agonists.