| 不同领域现实世界临床研究证据转化的应用策略 |
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| 引用本文： | 李昱佳,陈垂雄,黄丽红,汪旻晖,李晨,邱婧君,赵杨,谢海棠,王陵.不同领域现实世界临床研究证据转化的应用策略[J].中国临床医学,2021,28(5):744-750. |
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| 作者姓名： | 李昱佳 陈垂雄 黄丽红 汪旻晖 李晨 邱婧君 赵杨 谢海棠 王陵 |
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| 作者单位： | 陕西中医药大学公共卫生学院, 西安 710032;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;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;皖南医学院弋矶山医院, 芜湖 241000;CSCO生物统计学专家委员会RWE项目组;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;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;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（81773553，81903407，81803328，81973141）. |
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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。
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| 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 |
| 收稿时间： | 2021/9/7 0:00:00 |
| 修稿时间： | 2021/9/24 0:00:00 |
Research on the application strategy of transforming real-world clinical research data into evidence |
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| LI Yu-ji,CHEN Chui-xiong,HUANG Li-hong,WANG Min-hui,LI Chen,QIU Jing-jun,ZHAO Yang,XIE Hai-tang,WANG Ling.Research on the application strategy of transforming real-world clinical research data into evidence[J].Chinese Journal Of Clinical Medicine,2021,28(5):744-750. |
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| Authors: | LI Yu-ji CHEN Chui-xiong HUANG Li-hong WANG Min-hui LI Chen QIU Jing-jun ZHAO Yang XIE Hai-tang WANG Ling |
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| Affiliation: | School of Public Health, Shaanxi University of Chinese Medicine, Xi''an 710032, Shaanxi, China;Department of Health Statistics, Air Military Medical University, Xi''an 710032, Shaanxi, China;Department of Biostatistics, Zhongshan Hospital, Fudan University, Shanghai 200032, China;CSCO Biostatistics Expert Committee RWE Working Group;The First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui, China;CSCO Biostatistics Expert Committee RWE Working Group;Department of Health Statistics, Air Military Medical University, Xi''an 710032, Shaanxi, China;CSCO Biostatistics Expert Committee RWE Working Group;Beijing Technology Ltd, FOSUN Pharmacy, Beijing 100005, 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: | 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. |
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| Keywords: | real-world study real-world data real-world evidence application strategy |
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