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产生现实世界证据的现实世界数据应用现状及展望 |
李晨1,2, 黄丽红3,2, 邱婧君4,2, 王陵1,2, 秦伟栋1, 汪旻晖5,2, 赵杨6,2, 柏柳安宁7, 夏结来1
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1.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;2.CSCO生物统计学专家委员会RWE项目组;3.复旦大学附属中山医院生物统计室, 上海 200032;4.北京复星医药科技开发有限公司, 北京 100005;5.皖南医学院弋矶山医院药物评价中心, 芜湖 241000;6.南京医科大学公共卫生学院生物统计学系, 南京 211166;7.空军军医大学航空航天临床医学, 西安 710032
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摘要: |
现实世界数据(real-world data,RWD)在医药卫生领域的应用日益广泛。在RWD转化为现实世界证据(real-world evidence,RWE)的过程中也涌现了大量问题,其中主要关注点在于RWD相关的数据质量和数据标准问题。本文着眼于RWD来源、数据合规性,讨论其数据标准及其质量控制问题,并对其未来可能的发展途径作一展望。 |
关键词: 现实世界数据 现实世界证据 现实世界研究 数据质量 |
DOI:10.12025/j.issn.1008-6358.2021.20212010 |
分类号:R195.1 |
基金项目:国家自然科学基金青年基金(81803328,81903407),国家自然科学基金面上项目(81973141,81773553). |
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Applications and prospects of real-world data for real-world evidence |
LI Chen1,2, HUANG Li-hong3,2, QIU Jing-jun4,2, WANG Ling1,2, QIN Wei-dong1, WANG Min-hui5,2, ZHAO Yang6,2, BAILIU An-ning7, XIA Jie-lai1
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1.Department of Health Statistics, Air Military Medical University, Xi'an 710032, Shaanxi, China;2.CSCO Biostatistics Expert Committee RWE Working Group;3.Department of Biotatistics, Zhongshan Hospital, Fudan University, Shanghai 200032, China;4.Beijing Technology Ltd, FOSUN Pharmacy, Beijing 100005, China;5.Drug Evaluation Center, Yijishan Hospital of Wannan Medical College, Wuhu 241000, Anhui, China;6.Department of Biotatistics, School pf Public Health, Nanjing Medical University, Nanjing 211166, Jiangsu, China;7.Aerospace Clinical Medicine, Air Military Medical University, Xi'an 710032, Shaanxi, China
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Abstract: |
Real-world data (RWD) is widely used in the field of medicine and health. In the process of generating real-world evidence (RWE), a large number of problems have emerged, among which the main concerns are data quality and data standards related to RWD. This paper focuses on RWD sources and data compliance, discusses their quality control and data standardization, and prospects their development in the future. |
Key words: real-world data real-world evidence real-world research data quality |