Ⅰ期药物临床试验1例妊娠事件根本原因分析  

Root Cause Analysis of Pregnancy Events in Phase I Drug Trials

作　　者：段炼[1] 谢志红[1] 黄冬香[1] 黎笑媚 陈思含 戴丽萍 秦如斋[1] 叶丽卡[1] DUAN Lian;XIE Zhihong;HUANG Dongxiang;LI Xiaomei;CHEN Sihan;DAI Liping;QIN Ruzhai;YE Lika(PhaseⅠClinical Trial Center of The Second Affiliated Hospital of Guangzhou Medical University,Guangzhou,Guangdong 510000,China)

机构地区：[1]广州医科大学附属第二医院Ⅰ期临床试验中心,广东广州510000

出　　处：《今日药学》2022年第12期950-952,960,共4页Pharmacy Today

基　　金：广州市科技计划重点研发计划(202103000024)。

摘　　要：在药物临床试验中出现非预期妊娠事件,有些试验药物可能会给受试者及其子代的健康和安全造成极大的影响。本文针对Ⅰ期临床试验发生的1例妊娠事件进行根本原因分析,研究团队共同寻找该事件发生的根本原因并逐一制定解决措施,形成有效的防范流程和预防策略,并将该有效流程和措施应用到后续12项Ⅰ期临床试验项目中,经评价和验证取得良好效果,对今后预防该类事件的发生具有重要意义。If unexpected pregnancy events occur in drug clinical trials,some test drugs may have a great impact on the health and safety of subjects and their offspring.The root cause of a pregnancy event in phase I clinical trial was analyzed,the research team used the root cause analysis method to find the root cause of the event and develop solutions.Thus,formed an effective prevention process and prevention strategy.Then applied the effective process and measures to next 12 phase I clinical trial projects for evaluation and verification.After evaluation and verification,good results have been achieved,which is of great significance to prevent such events in the future.

关 键 词：Ⅰ期临床试验 受试者管理 妊娠事件 根本原因分析 

分 类 号：R969[医药卫生—药理学]