| 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 |
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| 引用本文： | 汪旻晖,赵杨,邓亚中,薛富波,谢海棠,姚晨.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[J].金属学报,2020,25(8):878-889. |
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| 作者姓名： | 汪旻晖 赵杨 邓亚中 薛富波 谢海棠 姚晨 |
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| 作者单位： | 1.皖南医学院弋矶山医院，芜湖 241000，安徽；;2.北京大学第一医院，北京 100034； ;3.南京医科大学，南京 211166，江苏；;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 |
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| 基金项目： | 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） |
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| 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。
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| 收稿时间： | 2020-04-03 |
| 修稿时间： | 2020-05-26 |
Comparison of policies and guidelines regarding using of real world data/real word evidence |
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| WANG Minhui,ZHAO Yang,DENG Yazhong,XUE Fubo,XIE Haitang,YAO Chen.Comparison of policies and guidelines regarding using of real world data/real word evidence[J].Acta Metallurgica Sinica,2020,25(8):878-889. |
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| Authors: | WANG Minhui ZHAO Yang DENG Yazhong XUE Fubo XIE Haitang YAO Chen |
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| Affiliation: | 1.Yijishan Hospital of Wannan Medical College, Wuhu 241000, Anhui, China;2.Peking University First Hospital, Beijing 100034, China;3. Nanjing Medical University, Nanjing 211166, Jiangsu, China;4.Beijing Trust Medicine Consulting Ltd., Beijing 100089, China;5. TopAlliance Biosciences Inc., Shanghai 201203, China |
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| Abstract: | 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. |
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| Keywords: | real world data real world evidence real world study policy guideline |
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