摘要
目的 论述人工智能在美国药物警戒中的应用现状,以期为我国的药品上市后监管工作提供借鉴。方法 通过查阅文献,从药品上市后监管视角,系统介绍人工智能相关定义和性能指标,美国食品药品监督管理局(FDA)应用人工智能的背景,FDA在人工智能的实践进展和考量,以及在药物警戒工作中的挑战等。结果 近10余年,FDA已广泛探索人工智能在药物警戒中的应用,现阶段FDA主要专注于人工智能处理和评价提交至FDA不良事件报告系统中的个例安全性报告(ICSRs),并在ICSRs关键信息提取和分析、ICSRs关联性评价等方面取得了主要进展。结论 借鉴FDA经验,建议我国加快引入人工智能技术、加强相关人员培训和人才培养与引进、建立人工智能社会技术与管理体系、促进人工智能领域国际领域交流和合作。
Objective To study the current applications of artificial intelligence in pharmacovigilance in the United States in order to provide reference for the supervision of China's postmarketing drugs.Methods Based on literature review,from the perspective of drug regulation,this article outlined the concepts and performance indicators related to artificial intelligence,the background of application,FDA's experience and challenges to pharmacovigilance from the perspective of monitoring of postmarketing drugs.Results In the past decade,FDA was extensively exploring the applications of artificial intelligence in pharmacovigilance.Currently,FDA focused on the applications of artificial intelligence in handling and evaluating individual safety reports submitted to the FDA adverse event reporting system,and major progress had been made in the retrieval and analysis of key information about ICSRs,as well as in causality assessment for ICSRs.Conclusion Based on the experience of FDA,it is recommended that we accelerate the introduction of artificial intelligence technologies,strengthen training of professionals,establish a social technology and management system for artificial intelligence and promote international exchanges and cooperation in this field.
作者
王涛
郑明节
刘红亮
王青
沈传勇
WANG Tao;ZHENG Mingjie;LIU Hongliang;WANG Qing;SHEN Chuanyong(Center for Drug Reevaluation,NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance,Beijing 100076,China;Pharmacovigilance Information Technology and Data Science Innovation Center of Tsinghua University,Beijing 100084,China)
出处
《中国药物警戒》
2023年第10期1129-1133,共5页
Chinese Journal of Pharmacovigilance
基金
国家科技重大专项重大新药创制(2017ZX09101001-001-003)
国家自然科学基金资助项目(72274065)。
关键词
人工智能
机器学习
药物警戒
不良事件
个例安全性报告
artificial intelligence(AI)
machine learning(ML)
pharmacovigilance
adverse events(AE)
individual case safety reports(ICSRs)
