临床试验期间智能化药物警戒体系的建设与应用  

Intelligent Pharmacovigilance System Construction for Clinical Trial Safety Evaluation and Risk Warning

作　　者：刘文东 刘洋 马润镒 陈艳 陈晓媛 王海学[1] LIU Wen-dong;LIU Yang;MA Run-yi;CHEN Yan;CHEN Xiao-yuan;WANG Hai-xue(Center for Drug Evaluation,National Medical Products Administration;Tsinghua Clinical Research Institute(TCRI),School of Medicine,Tsinghua University Office of Clinical Trial Institute,Beijing Tsinghua Changgung Hospital)

机构地区：[1]国家药品监督管理局药品审评中心 [2]清华大学医学院临床试验中心北京清华长庚医院临床试验机构办公室

出　　处：《中国食品药品监管》2023年第9期90-97,共8页China Food & Drug Administration Magazine

基　　金：2022年中国药品监督管理研究会课题(2022-Y-Y-004)。

摘　　要：临床试验期间个例安全性报告的审核在药物警戒监管中发挥着重要作用,同时也面临诸多挑战,包括依靠人工审核造成效率较低、安全性信息整合和整体评价的困难等。亟须利用大数据和人工智能(AI)对安全性数据进行自动挖掘和标准化处理,并构建实时信号评估和风险预警的解决方案。本文对智能化药物警戒体系建设的必要性及考量点进行了梳理,展示了临床试验安全性评价与风险预警智能化系统的开发实践和应用测试,并验证了智能化药物警戒系统构建的技术路线可行性,该系统的应用能够显著提升我国临床试验期间药物警戒的监管能力。The review of individual safety reports during clinical trials plays a crucial role in the pharmacovigilance system.However,it also faces various challenges,such as inefficiencies in manual review and difficulties in integrating and evaluating safety information comprehensively.There is an urgent need to use big data and artificial intelligence to automatically mine and standardize safety data to achieve real-time signal assessment and risk warning.This study analyzes the importance and considerations for building an intelligent pharmacovigilance system.Additionally,it showcases the development and application testing of intelligent tools for clinical trial safety evaluation and risk warning,and confirms the feasibility of a technical route for constructing an intelligent pharmacovigilance system.The application of such tools can significantly enhance the regulatory capabilities of pharmacovigilance during clinical trials in China.

关 键 词：药物警戒 新药研发 临床试验 风险预警 人工智能 

分 类 号：R95[医药卫生—药学]