基于真实世界数据的研究中设置外对照的现状及案例解读

External Control in Studies Using Real-world Data:Current Situation and Exemplar

在药品和医疗器械评价中,利用真实世界数据开展研究得到各国政府监管决策机构的重视,各国相继出台政策法规支持采用这类研究证据来评估产品的安全性和有效性。真实世界数据多源异构,开展高质量的真实世界数据研究需要多学科共同参与。在真实世界药品和医疗器械疗效比较研究中,当内对照难以获得时,设置合适的外对照有助于结果的合理解读和促进证据转化。

In the evaluation of drugs and medical devices,regulatory departments in various countries pay increasing attention to studies using real-world data,and have successively developed policies and regulations for applying real-world evidence to the safety and effectiveness evaluation of medical products.Real-world data are multi-source and heterogeneous,and conducting high-quality studies using these data involves multiple disciplines.In real-world drug and medical device comparative effectiveness research,when internal controls are not available,using an appropriate external control will be helpful for result and evidence transformation.