真实世界证据与随机对照试验:RCT DUPLICATE项目成果

Real-World Evidence and Randomized Controlled Trials: the Outcome of RCT DUPLICATE

随着医疗大数据的推广和使用,政策制定者和研究者逐渐聚焦于利用真实世界数据(RWD)产生真实世界证据(RWE)及其相关研究上。哈佛的研究团队于2018年率先发起了RCT DUPLICATE项目,通过利用RWD构建非随机的观察性研究,来重复随机对照试验(RCT)的结果,以期充分评估RWD产生RWE后达成的初期理论及进一步推广应用。本文在简要介绍了RCT DUPLICATE项目的背景和两个基于RWD形成的RWE并在此基础上获得审批的药物实例之后,对该项目的四个子项目的研究过程、研究进展及研究成果进行了重点阐述,希望对国内学者理解RWE的应用价值和日后深入地开展研究有所裨益。

With the promotion and use of medical big data,policy makers and researchers gradually focus on using real world data(RWD)to produce real world evidence(RWE)and related researches.In 2018,the harvard research team first launched the DUPLICATE RCT project to duplicate the results of RCTs by using RWD to construct non-random observational studies,so as to fully evaluate the initial theory after RWD produces RWE and further promote its application.In this paper,after the brief introduction of the background of the RCT DUPLICATE project and two drug approval examples based on the formation of RWE which produced by RWD,we mainly highlight the the research process,research progress and research achievements of four sub-projects in the project,hoping to help domestic scholars understand the application value of RWE and in-depth research in the future.