医疗器械临床试验中发现的问题及改进措施

Problems found in clinical trials of medical devices and improvement measures

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.