| 现实世界研究生态圈的构建与发展 |
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| 引用本文： | 邱婧君,王斯悦,李晨,夏结来,陈峰,黄丽红,王陵,赵杨. 现实世界研究生态圈的构建与发展[J]. 中国临床医学, 2021, 28(5): 723-731 |
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| 作者姓名： | 邱婧君 王斯悦 李晨 夏结来 陈峰 黄丽红 王陵 赵杨 |
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| 作者单位： | 北京复星医药科技开发有限公司, 北京 100005;CSCO生物统计学专家委员会RWE项目组;北京大学公共卫生学院流行病与卫生统计学系, 北京 100191;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;CSCO生物统计学专家委员会RWE项目组;南京医科大学公共卫生学院生物统计学系, 南京 211166;复旦大学附属中山医院生物统计室, 上海 200032;CSCO生物统计学专家委员会RWE项目组;南京医科大学公共卫生学院生物统计学系, 南京 211166;CSCO生物统计学专家委员会RWE项目组 |
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| 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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| 摘 要： | 现实世界证据（real-world evidence，RWE）由现实世界数据（real-world data，RWD）产生，经现实世界研究（real-world study，RWS）转化而来。科学的RWE可为决策提供参考依据，其产生有赖于系统性地构建和发展良性生态圈。本文梳理了RWD、RWS在产生RWE中的角色及转化机制，试图探讨构建现实世界研究良性生态系统的必要性及构成要素，并简要展望生态圈的发展趋势、机遇及挑战。
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| 关 键 词： | 现实世界证据 现实世界研究 现实世界数据 生态圈 生态系统 |
| 收稿时间： | 2021-08-31 |
| 修稿时间： | 2021-10-14 |
Construction and development of the ecosystem for real-world study |
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| QIU Jing-jun,WANG Si-yue,LI Chen,XIA Jie-lai,CHEN Feng,HUANG Li-hong,WANG Ling,ZHAO Yang. Construction and development of the ecosystem for real-world study[J]. Chinese Journal Of Clinical Medicine, 2021, 28(5): 723-731 |
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| Authors: | QIU Jing-jun WANG Si-yue LI Chen XIA Jie-lai CHEN Feng HUANG Li-hong WANG Ling ZHAO Yang |
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| Affiliation: | Beijing Technology Ltd, FOSUN Pharmacy, Beijing 100005, China;CSCO Biostatistics Expert Committee RWE Working Group;Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China;Department of Health Statistics, Air Military Medical University, Xi''an 710032, Shaanxi, China;CSCO Biostatistics Expert Committee RWE Working Group;Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing 211166, Jiangsu, China;Department of Biostatistics, Zhongshan Hospital, Fudan University, Shanghai 200032, China;CSCO Biostatistics Expert Committee RWE Working Group; Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing 211166, Jiangsu, China;CSCO Biostatistics Expert Committee RWE Working Group |
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| Abstract: | Real-world evidence (RWE) is generated via real-world study(RWS) based on real-world data (RWD). Reliable RWE is helpful for decision-making, which relies on a virtuous operating ecosystem. This study is aimed to propose the structure of RWS eco-system and to explore the virtuous mechanism for generating scientific evidence, as well as to discuss its future development. |
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| Keywords: | real-world evidence real-world study real-world data ecosphere ecosystem |
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