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不同领域现实世界临床研究证据转化的应用策略 |
李昱佳1,2, 陈垂雄2, 黄丽红3,4, 汪旻晖5,4, 李晨2,4, 邱婧君6,4, 赵杨7,4, 谢海棠5,4, 王陵2,4
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1.陕西中医药大学公共卫生学院, 西安 710032;2.空军军医大学军事预防医学系军队卫生统计学教研室, 西安 710032;3.复旦大学附属中山医院生物统计室, 上海 200032;4.CSCO生物统计学专家委员会RWE项目组;5.皖南医学院弋矶山医院, 芜湖 241000;6.北京复星医药科技开发有限公司, 北京 100005;7.南京医科大学公共卫生学院生物统计学系, 南京 211166
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摘要: |
参考已发布的政策法规指导意见,通过文献检索现实世界研究相关的专家共识指南,总结国内外现实世界临床研究不同领域的研究现况,归纳不同领域现实世界临床研究证据转化的观点,结合典型案例,为现实世界数据转化为现实世界证据的应用提供策略支持。 |
关键词: 现实世界研究 现实世界数据 现实世界证据 应用策略 |
DOI:10.12025/j.issn.1008-6358.2021.20212080 |
分类号:R195.1 |
基金项目:国家自然科学基金(81773553,81903407,81803328,81973141). |
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Research on the application strategy of transforming real-world clinical research data into evidence |
LI Yu-jia1,2, CHEN Chui-xiong2, HUANG Li-hong3,4, WANG Min-hui5,4, LI Chen2,4, QIU Jing-jun6,4, ZHAO Yang7,4, XIE Hai-tang5,4, WANG Ling2,4
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1.School of Public Health, Shaanxi University of Chinese Medicine, Xi'an 710032, Shaanxi, China;2.Department of Health Statistics, Air Military Medical University, Xi'an 710032, Shaanxi, China;3.Department of Biostatistics, Zhongshan Hospital, Fudan University, Shanghai 200032, China;4.CSCO Biostatistics Expert Committee RWE Working Group;5.The First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui, China;6.Beijing Technology Ltd, FOSUN Pharmacy, Beijing 100005, China;7.Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing 211166, Jiangsu, China
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Abstract: |
By consulting the published policies and regulations and reviewing the literature about the related expert consensus and guidelines on real-world research, we summarized the current status of real-world clinical researches which have been conducted at home and abroad, generalized the views on the transformation of real-world clinical research evidence in different fields combined with typical cases, and then provided supportive strategies for the application of real-world evidence generated by real-world data. |
Key words: real-world study real-world data real-world evidence application strategy |
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