真实世界证据在上市后药品安全性监测与评价中的应用价值

Application Values of Real-World Evidence in Post-Marketing Surveillances and Evaluation for Drug Safety

目的了解真实世界证据(real world evidence,RWE)在上市后药品安全性监测与评价中的应用价值。方法检索PubMed、Embase、Web of Science、Scopus、中国生物医学文献服务系统、中国知网、维普网、万方数据建库至2020年1月2日中与RWE及上市后药品安全性相关的文献,归纳RWE应用价值。结果及结论经课题组讨论和专家咨询将RWE在上市后药品安全性监测与评价中的应用价值,归纳为补充药品安全性证据、辅助药品上市后管理、支持临床决策及卫生政策、技术方法开发优化4个方面,并提供参考案例。

Objective To understand the application values of real-world evidence(RWE)in post-marketing surveillance and evaluation for drug safety.Methods Literatures related to RWE in post-marketing surveillance for drug safety were searched in PubMed,Embase,Web of Science,Scopus,SinoMed,CNKI,VIP,Wanfang Data from the establishment to January 2,2020.Results and conclusion After research team and expert consultation,application values of RWE in post-marketing surveillance and evaluation for drug safety was summarized into four aspects,including supplementing drug safety evidence,auxiliary drug post-marketing management,supporting clinical decision-making and health policies,as well as technical methods development and optimization.And for each aspect reference cases were provided.