临床试验期间不良事件管理的实践与思考

doi:10.19803/j.1672-8629.20230310

摘要/Abstract

摘要： 目的介绍临床试验期间不良事件（AE）的收集及管理实践,为临床试验期间药品安全管理工作提供建议。方法通过汇总我国法律法规并回顾相关文献,结合目前申办者的实际操作,对AE的收集时间、收集内容、收集方式、安全性信息上报以及分析报告等方面进行总结。结果随着我国相关法律法规的陆续出台,临床试验期间AE的收集和上报日益标准化,但在一些具体的AE管理实践中（如开始和结束时间、因果关系判断等）仍缺乏统一标准。结论临床试验期间收集的安全性数据是产品说明书中安全性信息的重要基础,对开展药品全生命周期药物警戒工作具有重要参考意义,申办者与研究者的通力合作、与药品监管机构的积极沟通尤为关键。

关键词: 临床试验, 不良事件, 收集, 管理, 安全, 药物警戒

Abstract: Objective To give advice about drug safety during clinical trials by introducing ways to manage adverse events(AE). Methods By summarizing the laws and regulations in China, reviewing the related literature, and outlining the sponsors' current practices, the time and ways to collect AE, the content to be collected, means of reporting of safety information and analysis of reports of AE were described. Results With the successive enforcement of laws and regulations in China, the collection and reporting of adverse events during clinical trials became increasingly standardized, but there was still a lack of uniform standards in some specific areas (e.g. start-end time or causality judgment). Conclusion Management of safety in clinical trials underlies the establishment of safety profiles in the product label as well as post-marketing safety surveillance. Therefore, close collaboration and active communication between health authorities, sponsors, and investigators are critical.

Key words: clinical trial, adverse event, collection, management, safety, pharmacovigilance

中图分类号:

R954

沈艳杰, 吴奕卿. 临床试验期间不良事件管理的实践与思考[J]. 中国药物警戒, 2023, 20(9): 982-986.

SHEN Yanjie, WU Yiqing. Management of adverse events during clinical trials[J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 982-986.

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