| 真实世界证据与随机对照试验：RCT DUPLICATE项目启动、实施、进展解读与启示（二） |
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| 引用本文： | 石舒原,刘佐相,赵厚宇,聂晓璐,韩晟,符祝,宋海波,姚晨,詹思延,孙凤.真实世界证据与随机对照试验：RCT DUPLICATE项目启动、实施、进展解读与启示（二）[J].中华流行病学杂志,2022,43(11):1835-1841. |
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| 作者姓名： | 石舒原 刘佐相 赵厚宇 聂晓璐 韩晟 符祝 宋海波 姚晨 詹思延 孙凤 |
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| 作者单位： | 北京大学公共卫生学院流行病与卫生统计学系, 北京 100191;中国康复科学所, 中国残联残疾预防与控制中心, 北京 100068;北京大学公共卫生学院流行病与卫生统计学系, 北京 100191;国家儿童医学中心, 首都医科大学附属北京儿童医院临床流行病与循证医学中心, 北京 100045;北京大学药学院药事管理与临床药学系, 北京 100191;海南省真实世界数据研究院, 博鳌乐城国际医疗旅游先行区管理局, 乐城 571437;国家药品监督管理局药品评价中心, 北京 100022;国家药品监督管理局药物警戒研究与评价重点实验室, 北京 100022;海南省真实世界数据研究院, 博鳌乐城国际医疗旅游先行区管理局, 乐城 571437;北京大学临床研究所, 北京 100191;北京大学公共卫生学院流行病与卫生统计学系, 北京 100191;北京大学第三医院临床流行病学研究中心, 北京 100191;北京大学公共卫生学院流行病与卫生统计学系, 北京 100191;海南省真实世界数据研究院, 博鳌乐城国际医疗旅游先行区管理局, 乐城 571437 |
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| 基金项目： | 国家自然科学基金（72074011）；中国药品监管科学行动计划第二批重点项目（［2021］37-10）；海南省博鳌乐城先行区真实世界研究专项计划（HNLC2022RWS012） |
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| 摘 要： | 随着医疗大数据的推广与应用，监管机构开始使用非随机化的真实世界证据（RWE）来评估医疗产品的有效性。本文简要介绍了哈佛大学研究团队于2018年发起RCT DUPLICATE项目的最新进展与研究成果，并结合我国医疗服务特点总结了相关研究经验，为国内学者今后开展相关RWE研究提供借鉴。
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| 关 键 词： | 随机对照试验 真实世界证据 真实世界数据 |
| 收稿时间： | 2022/5/13 0:00:00 |
Real-world evidence and randomized controlled trials: the initiation, implementation, progress interpretation and revelation of RCT DUPLICATE (part 2) |
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| Shi Shuyuan,Liu Zuoxiang,Zhao Houyu,Nie Xiaolu,Han Sheng,Fu Zhu,Song Haibo,Yao Chen,Zhan Siyan,Sun Feng.Real-world evidence and randomized controlled trials: the initiation, implementation, progress interpretation and revelation of RCT DUPLICATE (part 2)[J].Chinese Journal of Epidemiology,2022,43(11):1835-1841. |
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| Authors: | Shi Shuyuan Liu Zuoxiang Zhao Houyu Nie Xiaolu Han Sheng Fu Zhu Song Haibo Yao Chen Zhan Siyan Sun Feng |
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| Institution: | Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing 100191, China;China Institute of Rehabilitation Sciences, Center for Prevention and Control of Disability of China Disabled Persons Federation, Beijing 100068, China;Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing 100191, China;Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children''s Hospital, Capital Medical University, National Center for Children''s Health, Beijing 100045, China;Department of Pharmacy Management and Clinical Pharmacy, Peking University School of Pharmacy, Beijing 100191, China;Hainan Institute of Real World Data, the Admonistration of Boao Lecheng International Medical Tourism Pilot Zone, Lecheng 571437, China;Center for Drug Reevaluation, National Medical Products Administration, Beijing 100022, China;Key Laboratory for Research and Evaluation of Pharmacovigilance, National Medical Products Administration, Beijing 100022, China;Hainan Institute of Real World Data, the Admonistration of Boao Lecheng International Medical Tourism Pilot Zone, Lecheng 571437, China;Peking University Clinical Research Institute, Beijing 100191, China;Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing 100191, China;Clinical Epidemiology Research Center, Peking University Third Hospital, Beijing 100191, China; Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing 100191, China;Hainan Institute of Real World Data, the Admonistration of Boao Lecheng International Medical Tourism Pilot Zone, Lecheng 571437, China |
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| Abstract: | With the promotion and application of big medical data, non-interventional real-world evidence (RWE) has been used by regulators to assess the effectiveness of medical products. This paper briefly introduces the latest progress and research results of the RCT DUPLICATE Initiative launched by the research team of Harvard University in 2018 and summarizes relevant research experience based on the characteristics of China''s medical service to provide inspiration and reference for domestic scholars to conduct related RWE research in the future. |
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| Keywords: | Randomized controlled trial Real-world evidence Real-world data |
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