Online Program

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Wednesday, September 25
Wed, Sep 25, 8:30 AM - 9:45 AM
Thurgood Marshall South
From RCT to RWE: Continuum and Holistic Safety Evaluation

FDA Guidance on Meta-Analysis of Safety Evaluation (300952)

*Eugenio Andraca-Carrera, FDA/CDER/OTS/OB 

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.