Online Program

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Thursday, September 13
Thu, Sep 13, 4:15 PM - 5:30 PM
Lincoln 6
Statistical Challenges and Opportunities in Vaccine Development

Some Aspects of Meta-Analysis Use for Evaluation of Vaccines' Safety (300675)

*Rositsa B Dimova, FDA 

Keywords: vaccines, safety, meta-analysis

Safety data are collected systematically during the pre-market clinical development stage of vaccines to characterize their risk profile for benefit-risk evaluation purposes. Safety data are also collected post-approval for surveillance purposes or to study suspected associations between the use of a specific vaccine product and adverse events. Meta-analysis techniques are used to summarize/combine data from multiple trials or data sources during both the pre-market and post-approval stages. These techniques are especially useful for evaluation of safety events, since most severe adverse events usually are rare, and the individual studies have limited power to detect an increase in safety risk. Depending on the type of data that the meta-analysis is applied to, it is described as aggregated or individual participant data meta-analysis. In this presentation, we will discuss some of the challenges and opportunities associated with the application of meta-analysis techniques to safety data from vaccines’ studies.

*This presentation reflects the views of the author and should not be construed to represent FDA’s views or policies.