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

作　　者：姚晓莹 张靖雪 詹思延[1] Yao Xiaoying;Zhang Jingxue;Zhan Siyan(Department of Epidemiology and Biostatistics,Peking University School of Public Health,Beijing 100191,China)

机构地区：[1]北京大学公共卫生学院流行病与卫生统计学系

出　　处：《药物流行病学杂志》2019年第8期495-497,517,共4页Chinese Journal of Pharmacoepidemiology

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。In 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.

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 

分 类 号：R191.35[医药卫生—卫生事业管理]