文章摘要
梁欣,肖妍,张亚同,张梦琦,夏瑞,宁霄,王佳庆.医疗器械临床试验伦理审查意见的综合分析[J].中国药事,2024,38(1):24-27
医疗器械临床试验伦理审查意见的综合分析
Comprehensive Analysis of Ethical Review Opinions on Clinical Trials ofMedical Devices
投稿时间:2023-09-05  
DOI:10.16153/j.1002-7777.2024.01.003
中文关键词: 伦理审查  志愿者  申办者  医疗器械  临床试验研究
英文关键词: ethical review  volunteer  sponsor  medical devices  clinical trial
基金项目:国家重点研发计划(编号 2021YFC2401103)
作者单位
梁欣 首都医科大学附属北京潞河医院北京 101149 
肖妍 中国食品药品检定研究院北京 100050 
张亚同 北京医院北京 100730 
张梦琦 首都医科大学附属北京潞河医院北京 101149 
夏瑞 首都医科大学附属北京潞河医院北京 101149 
宁霄 中国食品药品检定研究院北京 100050 
王佳庆 首都医科大学附属北京天坛医院北京 100070 
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中文摘要:
      目的:研究不同注册分类医疗器械临床试验研究中伦理初始审查意见,为今后医疗器械临床试验伦理审查材料准备提供参考。方法:回顾性收集北京首都医科大学附属北京潞河医院伦理委员会2018年至2023年1月医疗器械临床试验伦理初始审查意见,并对问题进行分类,比较不同类型问题在不同注册分类医疗器械临床试验研究中及新版《医疗器械临床试验质量管理规范》颁布实施前后的发生率的差异。结果:合计收集50份伦理初始审查意见,主要集中于与志愿者知情同意及安全和获益相关的问题。两类问题的发生率分别为80.00%和66.00%。同时,两类问题的发生率均在新版《医疗器械临床试验质量管理规范》实施后呈现明显下降趋势。结论:提示相关从业人员在临床试验伦理材料准备的时候一定要把志愿者的权益和保障放在首位,并且不断更新对法律法规的认识,以规范项目的伦理申报。
英文摘要:
      Objective: To provide reference for the preparation of ethical review materials for future clinicaltrials of medical devices by studying the initial ethical review opinions of clinical trials of diff erent registrationclassifi cations of medical devices. Methods: The initial ethical review opinions of the ethics committee of Beijingluhe Hospital Affi liated to Capital Medical University from 2018 to 2023 on clinical trial of medical devices wereretrospectively collected, and the problems were classifi ed, and the diff erences in the incidence of diff erent typesof problems in clinical trial of medical devices with diff erent registration classifi cations and before and after thepromulgation and implementation of the new version of "Quality Management Standards for Clinical Trial ofMedical Apparatus and Instruments" were compared. Results: A total of 50 initial ethical reviews were collected,focusing on issues related to informed consent, safety and benefi ts of volunteerts. The incidence of the two types of problems was 80.00% and 66.00% respectively. Meanwhile, the incidence of the two types of problems showeda signifi cant downward trend after the implementation of the new version of the "Quality Management Standardsfor Clinical Trial of Medical Apparatus and Instruments". Conclusion: The article suggests that the relevantpractitioners must put the rights and interests of the volunteerts in the first place when preparing the ethicalmaterials for clinical trials, and constantly update their understanding of laws and regulations to standardize theethical declaration of the project.
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