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)

doi:10.19803/j.1672-8629.2020.02.12

中国药物警戒 ›› 2020, Vol. 17 ›› Issue (2): 121-125.
DOI: 10.19803/j.1672-8629.2020.02.12

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)

Jesse A. Berlin^1*, 方肖燕², 张勇晶²

1强生集团全球流行病学部,美国 08560;
2杨森中国研发中心流行病学部,上海 200233

收稿日期:2019-06-04 修回日期:2020-06-22 出版日期:2020-02-15 发布日期:2020-02-26
作者简介:Jesse A. Berlin,男,博士,流行病学与生物统计学。

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

Jesse A. BERLIN¹, FANG Xiaoyan², ZHANG Yongjing²

1Global Epidemiology, Johnson & Johnson. USA, 08560;
2Janssen China R&D, Epidemiology, Shanghai 200233, China

Received:2019-06-04 Revised:2020-06-22 Online:2020-02-15 Published:2020-02-26

摘要/Abstract

摘要： 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。

关键词: Meta分析, 药物安全性

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

中图分类号:

R994.11

Jesse A. Berlin, 方肖燕, 张勇晶. 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)[J]. 中国药物警戒, 2020, 17(2): 121-125.

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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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

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