真实世界研究在医疗器械临床评价中的应用  

Application of Real World Study in Clinical Evaluation of Medical Devices

作　　者：杜玮[1] 文美 Du Wei;Wen Mei(Shenzhen Children's Hospital Drug Clinical Trial Institutions,Shenzhen Guangdong 518000,China)

机构地区：[1]深圳市儿童医院药物临床试验机构,广东深圳518000

出　　处：《医疗装备》2022年第1期187-191,共5页Medical Equipment

摘　　要：该文通过阐明真实世界研究(RWS)的相关概念,以及分析RWS与随机对照试验(RCT)的区别及联系、医疗器械临床评价的发展趋势,并结合RWS在医疗器械临床评价中的发展与应用,剖析将真实世界数据(RWD)应用于医疗器械临床评价中的各类情形,同时结合实际指出RWS在开展过程中存在的问题,探讨如何利用RWS在医疗器械临床评价中发挥重要作用,以及如何利用RWS将其数据更好地应用于医疗器械的上市、监管、成果转化及全生命周期管理中。By clarifying the relevant concepts of real world study(RWS),as well as analyzing the differences and links between RWS and randomized controlled trials(RCT),this article further analyzed the development trend of clinical evaluation of medical devices,and then combining with the development and application of RWS in clinical evaluation of medical devices,dissected the various situations in which real world data(RWD)are applied to clinical evaluation of medical devices,and meanwhile point out the problems existing in the course of RWS.At last,this paper discussed how to make RWS play an important role in the clinical evaluation of medical devices,how to let the data of RWS better apply to the listing,supervision,achievement transformation and whole life cycle management of medical device products.

关 键 词：真实世界研究 真实世界数据 真实世界证据 医疗器械 临床评价 临床试验 临床证据 

分 类 号：R197.39[医药卫生—卫生事业管理]