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| 真实世界证据与随机对照试验：RCT DUPLICATE项目概述 |
| Real world Evidence and Randomized Controlled Trials: the Overview of RCT DUPLICATE |
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| DOI： |
| 中文关键词: 真实世界证据 随机对照试验 非随机观察性研究 RCT DUPLICATE项目 |
| 英文关键词:Randomized controlled trial Real world evidence Non randomized observational studies RCT DUPLICATE |
| 基金项目: |
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| 中文摘要: |
| 摘 要近年来，利用真实世界数据（real world data, RWD）通过恰当的设计和分析产生真实世界证据（real world evidence, RWE），已经成为学术界、工业界和监管机构共同关注的话题。但RWE能否代替来自严格受控的随机对照试验（RCT）产生的证据仍不确定。为此，2018年美国启动了RCT DUPLICATE项目，旨在利用真实世界证据，通过非随机的观察性研究来重复RCT的结果。本文回顾了RCT DUPLICATE产生的背景，重点介绍了该项目的研究团队、研究目的、研究内容及项目意义，以期促进国内学者更好地理解RWE的适用范围和应用价值。 |
| 英文摘要: |
| ABSTRACTIn recent years, the use of real world data (RWD) to generate real world evidence (RWE) through proper design and analysis has become a topic of common concern in academia, industry and regulatory bodies. However, whether RWE can substitute for the evidence generated by a strictly controlled randomized controlled trial (RCT) remains uncertain. Therefore，the US launched the RCT DUPLICATE project, which aims at using real world evidence generated by non randomized observational studies to replicate the results of RCTs. This paper reviews the background of the RCT DUPLICATE project, highlights the research team, research purposes, research content and the significance of project implementation. So that the domestic scholars can have a better understanding of the scope and application value of RWE. |
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