国内医疗器械及体外诊断试剂临床试验暂停终止的原因与建议  

Reasons and suggestions for suspension and termination of domestic medical device and in vitro diagnostic reagent clinical trials

作　　者：夏佳靖 汪燕 黄飞 程国华[1] XIA Jiajing;WANG Yan;HUANG Fei;CHENG Guohua(College of Pharmacy,Jinan University,Guangzhou 511400,China)

机构地区：[1]暨南大学药学院,广东广州511400 [2]南方医科大学第三附属医院,广东广州510630 [3]默沙东(中国)投资有限公司,上海200233

出　　处：《现代医院》2025年第4期493-496,共4页Modern Hospitals

基　　金：国家药品监督管理局药品审评检查大湾区分中心监管科学研究课题(GBA-JGKX-2403)。

摘　　要：目的分析国内医疗器械临床试验项目暂停终止的具体原因。基于分析结果为参与试验的各方提出参考建议和完善措施。方法采用资料收集法收集国内医疗器械临床试验样本,走访多家医疗机构,对于状态处于暂停或终止的项目,采取现场采访研究团体和临床试验机构办工作人员、查阅研究者文件夹中存放的“项目暂停/终止函”、电话咨询项目的临床监察员(clinical research associate,CRA)等方式来获知项目暂停或终止的具体原因;走访一家合同研究组织(contract research organization,CRO)商业公司,对于项目状态为暂停或终止的项目,采取现场访谈或电话咨询项目经理、CRA中办方相关人员等方式获知项目暂停或终止的具体原因。通过描述性分析法总结暂停终止原因及其暂停终止率。结果统计分析得到我国的医疗器械临床试验暂停终止率为17.30%,其中在医疗机构收集到的样本中暂停终止率为16.04%,在CRO公司收集到的医疗器械临床试验暂停终止率为21.30%。导致国内医疗器械临床试验总体暂停终止的原因包括申办方策略调整、医疗机构或研究团队原因、产品或方案设计缺陷、改用同类产品数据注册、试验结果相关、第三方服务商相关、其他原因、安全性相关、疫情原因、法规更新、知情困难。结论导致国内医疗器械临床试验项目暂停终止的原因具有复杂性和多样性,统计分析得到我国的医疗器械临床试验暂停终止率为17.30%。Objective To analyze the specific reasons for the suspension and termination of domestic medical device clinical trial projects.Based on the analysis results,provide reference suggestions and improvement measures for all parties involved in the trials.Methods Data collection method was used to collect samples of domestic medical device clinical trials,and visits were made to multiple medical institutions.For projects that were suspended or terminated,specific reasons were obtained through on-site interviews with research teams and clinical trial institution staff,reviewing“Project Suspension/Termination Letters”stored in the investigator’s folder,and telephone consultations with clinical research associates(CRAs)of the projects.A contract research organization(CRO)commercial company was also visited,and specific reasons for project suspension or termination were obtained through on-site interviews or telephone consultations with project managers,CRA-related personnel,etc.Descriptive analysis was used to summarize the reasons for suspension and termination and their rates.Results Statistical analysis showed that the suspension and termination rate of medical device clinical trials in China was 17.30%,with a rate of 16.04%in samples collected from medical institutions and 21.30%in samples collected from CRO companies.The reasons leading to the overall suspension and termination of domestic medical device clinical trials included sponsor strategy adjustments,medical institution or research team issues,product or design defects,switching to registration using data from similar products,trial result-related factors,third-party service provider issues,other reasons,safety-related factors,pandemic reasons,regulatory updates,and difficulties in obtaining informed consent.Conclusion The reasons for the suspension and termination of domestic medical device clinical trial projects are complex and diverse,with a statistical analysis showing a rate of 17.30%in China.

关 键 词：临床试验 医疗器械 体外诊断试剂 暂停 终止 

分 类 号：R951[医药卫生—药学] R197