Keywords: Meta-analysis, safety, efficacy, bias
A well-designed meta-analysis can provide valuable information for safety and effectiveness assessment in the regulation of medical products. However, there are many statistical considerations in using meta-analysis for regulatory decision making. Meta-analysis may be subject to bias such as publication bias; heterogeneity in the study population, study design and study conduct, etc. can create difficulties in generalizing statistical inference and interpreting results. The quality assessment of selected publications in meta-analysis such as blinding, missing data, etc. is crucial in the evaluation. In this roundtable, we will share our thoughts in using meta-analysis for regulatory decision making.