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

doi:10.19803/j.1672-8629.2020.02.12

Abstract

Abstract: 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.

Key words: Meta-analysis, drug safety

CLC Number:

R994.11

Jesse A. BERLIN, FANG Xiaoyan, ZHANG Yongjing. 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[J]. Chinese Journal of Pharmacovigilance, 2020, 17(2): 121-125.

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