真实世界数据/真实世界证据应用的政策法规及指导原则的比较研究  

Comparison of policies and guidelines regarding using of real world data/real word evidence

作　　者：汪旻晖[1] 赵杨[3] 邓亚中 薛富波 谢海棠[1] 姚晨[2] WANG Minhui;ZHAO Yang;DENG Yazhong;XUE Fubo;XIE Haitang;YAO Chen(Yijishan Hospital of Wannan Medical College,Wuhu 241000,Anhui,China;Peking University First Hospital,Beijing 100034,China;Nanjing Medical University,Nanjing 211166,Jiangsu,China;Beijing Trust Medicine Consulting Ltd.,Beijing 100089,China;TopAlliance Biosciences Inc.,Shanghai 201203,China)

机构地区：[1]皖南医学院弋矶山医院,安徽芜湖241000 [2]北京大学第一医院,北京100034 [3]南京医科大学,江苏南京211166 [4]北京信立达医药科技有限公司,北京100089 [5]君实生物医药科技股份有限公司,上海201203

出　　处：《中国临床药理学与治疗学》2020年第8期878-889,共12页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：国家自然科学基金面上项目(81173134);皖南医学院弋矶山医院科技创新团队“攀峰”培育计划项目(KPF2019016)。

摘　　要：国内外监管机构已经对如何利用真实世界数据(real world data,RWD)和真实世界证据(real world evidence,RWE)支持医药产品研发和监管决策开展了多项讨论,并体现在相关指导原则和框架文件中。我国RWD/RWE应用的开展与推广较国际先进监管机构晚,体系和条件与发达国家和地区存在差距。本文旨在通过对各地区现行RWD/RWE应用相关的政策法规及技术指导原则进行要素分析和比较研究,希望通过基于资料总结讨论各地区关于RWD/RWE的应用现状,为探索适合中国的RWD/RWE应用策略提供有益的参考。China and foreign regulators have conducted multiple discussions on how to use Real World Data(RWD)and Real World Evidence(RWE),also published relevant guidelines and framework files.The development and promotion of RWD/RWE application in China is relatively late,and there is a gap of systems and conditions between China and developed countries.This article aims to learn from advantage experiences of other countries and provide some referential ideas for exploring a strategy of RWD/RWE applications suitable for China by analyzing and comparing the current RWD/RWE application-related policies and guidelines in different regions.

关 键 词：真实世界数据 真实世界证据 真实世界研究 政策法规 指导原则 

分 类 号：R969[医药卫生—药理学]