国际医学科学组织理事会（CIOMS）第十工作组关于药物安全性的证据合成和Meta分析的报告摘要（一）

A Summary of Report of the Council for International Organizations of Medical Sciences (CIOMS) Working Group Ⅹ on Evidence Synthesis and Meta-Analysis for Drug Safety

Meta分析是循证医学中最重要的定量研究方法,目前已被广泛应用于药物研发期间及上市后有效性的评估中。近年来Meta分析在药物安全性上的应用对于FDA的决策影响愈见显著,然而目前各方对于该应用的认识有限。因此,本文将介绍国际医学科学组织理事会CIOMS第十工作组(CIOMS X)起草指南文件的目的和目标读者,并就Meta分析的定义,计划及执行过程中的要点进行简要介绍。

Meta-analysis is the most important quantitative method in evidence-based medicine and has been widely applied to assess the efficacy during(and after) drug development. Recently, Meta-analysis used in studying safety outcomes has had a major impact on clinical or drug regulatory decisions. However, due to the difference of study design between safety and efficacy study, there are currently a number of challenges to the use of Meta-analysis to study drug safety. Hence, this paper is intended to present the aims of the CIOMS X guidance document, including comments on the intended audiences for the document. We present the key issues in Meta-analysis for drug safety, focusing on Meta-analyses of randomized clinical trials.