医疗器械临床试验监督抽查问题分析与探讨  

Analysis and discussion of problems founded in supervision and random inspection of medical device clinical trials

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》2021年第2期109-112,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：对2016—2018年国家药品监督管理局公布的医疗器械临床试验监督抽查结果进行汇总统计,并以《医疗器械临床试验检查要点及判定原则》为依据,对公布的问题进行分类分析,针对性地提出改进措施。纵观所有公布的问题,目前我国医疗器械临床试验质量还需进一步提升,临床试验各参与方都需加强学习与合作,以确保临床试验数据真实性、完整性、规范性。The results of supervision and random inspection of medical device clinical trials published by the National Medical Products Administration from 2016 to 2018 were summarized and statistically analyzed. Based on the Checkpoints and Principles of Medical Device Clinical Trials, the published problems were classified and analyzed, and improvement measures were put forward. Overall, the quality of clinical trials of medical devices in China needs to be further improved, and all participants in clinical trials need to strengthen learning and cooperation to ensure the authenticity, completeness, and normativity of clinical trial data.

关 键 词：医疗器械 临床试验 影响因素分析 

分 类 号：R197.39[医药卫生—卫生事业管理] R969.4[医药卫生—公共卫生与预防医学]