现代医院2025，Vol.25Issue(4)：493-496,4.DOI:10.3969/j.issn.1671-332X.2025.04.001
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 diag-nostic reagent clinical trials
摘要
Abstract
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 in-volved 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 Let-ters"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 termi-nation 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 analy-sis 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 insti-tution or research team issues,product or design defects,switching to registration using data from similar products,trial result-re-lated 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 de-vice 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Key words
Clinical trials/Medical devices/In vitro diagnostic reagents/Suspension/Termination分类
药学引用本文复制引用
夏佳靖,汪燕,黄飞,程国华..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[J].现代医院,2025,25(4):493-496,4.基金项目
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) （GBA-JGKX-2403）
