摘要
随着医疗健康数据的快速增长,真实世界数据(real world data,RWD)分析为药物警戒工作带来了新的机遇,成为传统药品不良反应监测模式的有益补充。本文通过介绍几种主要的RWD类型,包括电子健康档案数据、医疗保险数据、注册登记数据、社交媒体数据和多源整合数据的定义和常见数据库举例,并对各种类型数据应用于相关药品安全性监测和评价的案例进行分析,总结了RWD在药物警戒中的应用范畴、优势和局限性,以期为我国利用RWD开展药物警戒活动相关研究的探索和实践提供参考。
With the rapid digitalization of healthcare data,the analysis of real world data(RWD)analyses has brought new opportunities for pharmacovigilance and serves as a valuable complement to traditional adverse drug reaction surveillance.This article provides an overview of the definition,database examples and case analysis of major types of RWD in pharmacovigilance,including electronic health record data,health insurance data,registry data,social media data,and multisource integrated data.It summarizes the application scope,strengths and limitations of RWD in pharmacovigilance,aiming to provide references for exploring and implementing RWD-based pharmacovigilance research and practices in China.
作者
王蔷
吉永卓成
窦丽霞
WANG Qiang;Yoshinaga Takunari;DOU Li-xia(Bristol-Myers Squibb(China)Investment Co.,Ltd.;Bristol-Myers Squibb K.K.)
出处
《中国食品药品监管》
2023年第10期60-67,共8页
China Food & Drug Administration Magazine
