Key Issues in Meta-Analysis with Applications to Safety Data
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*Richard Forshee, U.S. Food and Drug Administration 

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Meta-analysis can be a useful tool for identifying and evaluating safety signals, but it presents its own unique set of research challenges. This presentation will discuss some of the key issues in meta-analysis including: defining the research question, identifying relevant studies, minimizing publication bias, addressing study comparability, analyzing the data, conducting sensitivity analysis, and reporting the results. Special issues regarding meta-analysis of safety data will be discussed and illustrated with a computer simulation.