真实世界数据在医疗器械上市后监测中的应用进展  

Progress in the application of real-world data in post-market surveillance of medical devices

作　　者：滕颖影 李柴全 胥洋 唐迅[1] 高培[1,3] TENG Yingying;LI Chaiquan;XU Yang;TANG Xun;GAO Pei(Department of Epidemiology and Biostatistics,School of Public Health,Peking University,Beijing 100191,China;Center for Medical Device Evaluation,NMPA,Beijing 100081,China;Center for Real-world Evidence Evaluation,Peking University Clinical Research Institute,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系,北京100191 [2]国家药品监督管理局医疗器械技术审评中心,北京100081 [3]北京大学临床研究所真实世界证据评价中心,北京100191

出　　处：《中国药物警戒》2022年第3期233-238,243,共7页Chinese Journal of Pharmacovigilance

基　　金：国家重点研发计划(2020YFC2003503);中国药品监管科学行动计划重点项目:真实世界数据用于医疗器械临床评价的方法学研究。

摘　　要：目的梳理总结真实世界数据在医疗器械上市后监测中的应用进展,为医疗器械监督管理部门提供监管依据。方法从中国、美国和欧盟监管机构官网检索相关政策法规文件,同时检索国内外相关文献。结果各国监管机构相继发布并一定程度更新了真实世界数据相关指南,唯一器械标识、通用数据模型、分布式健康数据网络等技术的发展有助于将多个数据源链接形成规模更大的数据库,自然语言处理技术则推动了电子病历/健康数据在上市后监测中的应用,越来越多的登记数据库,以及数字健康、可穿戴器械自身记录的数据均为上市后监测提供了有别于传统不良事件数据库的数据源,而安全信号自动监测技术则提高了医疗器械上市后监测的效率和及时性。结论可用真实世界数据源日益增加和自动监测技术的发展推动真实世界数据在医疗器械上市后监测中的应用。Objective To summarize the progress of applying real-world data in medical device post-market surveillance,so as to provide supervision basis for medical device supervision and management department.Methods Relevant regulation and guidance documents were searched on the NMPA,FDA and EU official website,and relevant literatures were also searched.Results Regulatory agencies from different countries successively issued and updated the guidelines for the application of real-world data.The development of the technologies,such as unique device identification,common data models,and distributed health data networks,helped link multiple data sources to form a larger database.Natural language processing technology also promoted the application of electronic medical records/health data in post-market surveillance.More and more registry data,as well as the data recorded by digital health and wearable devices,provided post-market surveillance extra data source that was different from traditional databases for collecting adverse events.The algorithms to detect safety signal automatically improved the efficiency and immediacy of the medical device post-market surveillance.Conclusion The increasing availability of real-world data sources and the development of automatic detection technologies have promoted the application of real-world data in post-market monitoring of medical devices.

关 键 词：真实世界数据 医疗器械 上市后监测 真实世界证据 法规 登记数据 主动监测 

分 类 号：R955[医药卫生—药学]