摘要
回顾性总结了某院2015—2019年开展的17项医疗器械临床试验质控中发现的问题,从研究者、申办方、药物临床试验机构办公室、国家法规4个角度分析了问题产生的原因。结合医疗器械临床试验现状提出加强对研究者的培训、强化申办方角色、建立完善的质量控制体系及完善相应法规的改进措施,为医疗器械临床试验的管理者和实施者提供了参考。
The problems found in the quality control of 17 medical device clinical trials carried out by some hospital from 2015 to 2019 were retrospectively summarized,and the causes of the problems were analyzed from four perspectives:investigators,sponsors,drug clinical trial organization offices and national regulations.Some improvement measures to enhance the training of investigators,strengthen the role of sponsors,establish a sound quality control system and complete the corresponding regulations were proposed in relation to the current situation of medical device clinical trials,which provided references for the managers and implementers of medical device clinical trials.
作者
潘辛梅
李明红
谢江川
谢林利
陈勇川
PAN Xin-mei;LI Ming-hong;XIE Jiang-chuan;XIE Lin-li;CHEN Yong-chuan(Department of Pharmacy,the First Affiliated Hospital of Army Medical University,Chongqing 400038,China)
出处
《医疗卫生装备》
CAS
2021年第6期75-78,83,共5页
Chinese Medical Equipment Journal
基金
重庆市科学技术委员会资助项目(cstc2018jsyj-zdcxX0079)。
关键词
医疗器械
临床试验
质量控制
medical device
clinical trial
quality control