Although the value of meta-analyses in drug efficacy is established, their role in evaluating harm needs consideration. The role of meta-analyses and the reporting of methodological considerations in published meta-analyses will be discussed. The panel will also focus on additional questions such as when are these studies most useful to inform clinical and/or regulatory decision making, and what are the critical elements that should be included in a framework to assess reporting of methodological considerations of meta-analyses in drug safety?

Learning Objectives:
Describe the role and the methodological limitations of meta-analysis of RCTs in drug safety
Discuss the extent of reporting of critical evaluation of pertinent methodological considerations in recently published meta-analyses evaluating drug safety issues.