2016—2020年四川省医疗器械临床试验监督抽查结果的分析与探讨  

Analysis and discussion on results of supervision and random inspection of medical device clinical trials in Sichuan province from 2016 to 2020

作　　者：李佳[1] 韩祺 王琪[1] 李灏来[1] 梁新华[1] LI Jia;HAN Qi;WANG Qi;LI Hao-lai;LIANG Xin-hua(State Institute of Medical Device Clinical Trial/National Clinical Research Center for Oral Diseases,West China Hospital of Stomatology,Sichuan University,Chengdu SICHUAN 610041,China)

机构地区：[1]四川大学华西口腔医院国家医疗器械临床试验机构/国家口腔疾病临床研究中心,四川成都610041

出　　处：《中国新药与临床杂志》2022年第4期215-219,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：汇总2016—2020年四川省药品监督管理局公布的医疗器械临床试验监督抽查结果,梳理统计公布的所有问题并分类概括,包括试验前准备不充分、受试者权益保障不全面、记录与报告不规范、临床试验方案执行不严格、试验医疗器械管理粗放等方面。从申办方、机构、研究者等角色进行原因剖析,从临床试验文件管理体系建设、软硬件设施配备、人员培训等方面提出相应的改进措施,以期为后续医疗器械临床试验的规范化开展提供参考。The results of inspection on medical device clinical trial published by the SiChuan Medical Products Administration(SCMPA) from 2016 to 2020 were summarized, and all the problems published were sorted, counted and summarized by category. These problems included insufficient pre-trial preparation, incomplete protection of the subjects’ interests, irregular recording and reporting, lax implementation of clinical trial protocols, extensive management of experimental medical devices, etc. The reasons were analyzed in depth from the perspective of sponsor, institute, investigator,etc.,and suggestions were finally proposed including the corresponding rectification measures on files system building,hardware and software facilities, and personnel training. We hope the summary, analysis, and suggestion in this article could be reference for normalizing medical device clinical trials in future.

关 键 词：医疗器械 临床试验 影响因素分析 措施探讨 

分 类 号：R969.4[医药卫生—药理学]