| 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].Chinese journal of Epidemiology,2022,43(11):1835-1841 |
| 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） |
| Real-world evidence and randomized controlled trials: the initiation, implementation, progress interpretation and revelation of RCT DUPLICATE (part 2) |
| Received:May 13, 2022 |
| DOI：10.3760/cma.j.cn112338-20220513-00409 |
| KeyWord: 随机对照试验 真实世界证据 真实世界数据 |
| English Key Word: Randomized controlled trial Real-world evidence Real-world data |
| FundProject: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） |
| Author Name | Affiliation | E-mail | | Shi Shuyuan | 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 | | | Liu Zuoxiang | Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing 100191, China | | | Zhao Houyu | Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing 100191, China | | | Nie Xiaolu | 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 | | | Han Sheng | Department of Pharmacy Management and Clinical Pharmacy, Peking University School of Pharmacy, Beijing 100191, China | | | Fu Zhu | Hainan Institute of Real World Data, the Admonistration of Boao Lecheng International Medical Tourism Pilot Zone, Lecheng 571437, China | | | Song Haibo | 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 | | | Yao Chen | 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 | | | Zhan Siyan | 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 | | | Sun Feng | 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 | sunfeng@bjmu.edu.cn |
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| Abstract: |
| 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。 |
| English 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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