基于常规收集健康医疗数据的上市药品安全性评价研究设计和分析技术专家共识  

Expert consensus on design and statistical analysis to evaluate drug safety using routinely collected health data

作　　者：王雯[1,2] 刘梅 何俏[1,2] 田春华 宋海波 王涛 谭婧 任燕 高培[4] 彭晓霞 温泽淮[6] 舒啸尘 邹康[1,2] 沈传勇[3] 孙鑫[1,2] WANG Wen;LIU Mei;HE Qiao;TIAN Chunhua;SONG Haibo;WANG Tao;TAN Jing;REN Yan;GAO Pei;PENG Xiaoxia;WEN Zehuai;SHU Xiaochen;ZOU Kang;SHEN Chuanyong;SUN Xin(Chinese Evidence-based Medicine Center,West China Hospital,Sichuan University,Chengdu Sichuan 610041,China;NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan,Haikou Hainan 570100,China;Center for Drug Reevaluation,NMPA/NMPA,Key Laboratory for Research and Evaluation of Pharmacovigilance,Beijing 100022,China;Department of Epidemiology and Biostatistics,Peking University Health Science Center,Beijing 100191,China;Center for Clinical Epidemiology and Evidence-based Medicine,Beijing Children’s Hospital,Capital Medical University,Beijing 100045,China;Key Unit of Methodology in Clinical Research,Guangdong Provincial Hospital of Chinese Medicine,Guangzhou Guangdong 510120,China;Department of Epidemiology and Biostatistics,School of Public Health,Medical College Soochow University,Suzhou Jiangsu 215123,China)

机构地区：[1]四川大学华西医院中国循证医学中心,四川成都610041 [2]国家药品监督管理局海南真实世界数据研究与评价重点实验室,海口海南570100 [3]国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京100022 [4]北京大学公共卫生学院流行病与卫生统计学系,北京100191 [5]国家儿童医学中心,首都医科大学附属北京儿童医院,临床流行病学与循证医学中心,北京100045 [6]广东省中医院临床研究方法学重点研究室,广东广州510120 [7]苏州大学公共卫生学院流行病与卫生统计学系,江苏苏州215123

出　　处：《中国药物警戒》2022年第1期7-12,共6页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金青年科学基金项目(72104155);四川省青年科技创新研究团队(2020JDTD0015);中国中医药循证医学中心“业务研究室主任专项”(2020YJSZX-3);国家药品监督管理局“上市后药品的安全性监测和评价方法研究项目”(HX-H2003033)。

摘　　要：作为真实世界数据的重要组成,常规收集的健康医疗数据(RCD)已广泛应用到上市后药品安全性评价。但如何生成高质量的RCD证据支持上市后药品安全性监管决策,在研究设计和分析上还存在挑战。本专家共识通过阐明RCD的定义、应用,并针对研究设计、数据分析提出基于RCD的上市后药品安全性评价基本要求及注意事项,以期促进我国高质量的研究证据的生产及应用。As an important source for real world data,routinely collected health data(RCD)have been widely used for drug safety evaluation.However,the production of trustworthy evidence informing drug safety regulatory decision still have substantial challenges,such as inadequate research capacity in design and analysis.In this expert consensus,we introduced the concept and applications of RCD in drug safety evaluation;summarize the issues and proposed recommendations for study design and analysis.We hope this paper may improve the quality of production and use of evidence generating from RCD.

关 键 词：真实世界数据 药品安全性评价 常规收集的健康医疗数据 

分 类 号：R994.11[医药卫生—毒理学]