| 石舒原,刘佐相,赵厚宇,聂晓璐,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（一）[J].Chinese journal of Epidemiology,2022,43(11):1828-1834 |
| 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（一） |
| Real-world evidence and randomized controlled trials: the initiation, implementation, progress interpretation and revelation of RCT DUPLICATE (part 1) |
| Received:May 13, 2022 |
| DOI：10.3760/cma.j.cn112338-20220513-00408 |
| KeyWord: 真实世界证据 真实世界数据 模拟 |
| English Key Word: Real-world evidence Real-world data Emulation |
| 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 | | | 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: |
| 近些年，医疗产品监管机构开始重新审视真实世界证据（RWE）对监管决策的潜在价值。RWE能否代替金标准随机对照试验（RCT）产生的证据尚不确定。哈佛大学研究团队于2018年发起了RCT DUPLICATE项目，旨在利用医疗索赔数据库模拟30个RCT，以探索效力-效果差距的量化方法并解释其潜在来源，增强RWE的可信度。本文回顾了RCT DUPLICATE项目的产生背景，重点介绍RCT DUPLICATE项目的研究目的、研究设计和实施流程，以期帮助国内学者更好地理解RWE的适用范围和应用价值。 |
| English Abstract: |
| In recent years, researchers, pharmaceutical companies, and political makers gradually using more real-world data (RWD) to produce real-world evidence (RWE) for policy-making. A research team of Harvard University launched the RCT DUPLICATE project in 2018, aiming to replicate 30 randomized controlled trials using the medical claims database in order to explore methods for quantifying the efficacy-effectiveness gap and explain its potential sources, to enhance the credibility of the RWE. This paper reviews the background of RCT DUPLICATE Initiative, highlights the research purposes, research design and implementation process of the RCT DUPLICATE Initiative, to help domestic scholars better understand the scope and application value of RWE. |
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