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.
作者
汪旻晖
赵杨
邓亚中
薛富波
谢海棠
姚晨
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)
出处
《中国临床药理学与治疗学》
CAS
CSCD
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)。
