医疗器械与药物临床试验的实施差异与质控对策

发布时间：2018-03-31 12:07

本文选题：医疗器械　切入点：临床试验　出处：《中国新药与临床杂志》2016年02期

【摘要】：随着近年来我国医疗器械行业高速发展,医疗器械新产品不断涌现,高质量的医疗器械临床试验是保证获得可靠临床试验证据,从而使产品获得药监部门批准、进入临床使用的必要条件。2014年末国家食品药品监督管理总局(CFDA)新发布的《医疗器械临床试验机构认定管理办法(征求意见稿)》,将会驱动更多的医院在原有药物临床试验机构的基础上,专门建立医疗器械临床试验机构。本文从试验审批、试验风险、试验周期、试验器械、研究参加人员和研究报告评审等方面,整理和归纳了医疗器械临床试验与药物临床试验的实施差异,并提出了相应质控对策,希望能为计划建立医疗器械临床试验机构的医院提供参考。
[Abstract]:With the rapid development of medical device industry in China in recent years, new products of medical device are constantly emerging. The high quality clinical trial of medical device is to ensure the reliable clinical trial evidence, so that the product can be approved by the drug control department. Necessary conditions for Clinical use. At the end of 2014, the State Administration of Food and Drug Administration (CFDAA) issued the newly issued measures for the recognition and Management of Clinical testing institutions of Medical Devices (draft for opinions), which will drive more hospitals to face the original drugs. On the basis of the bed test mechanism, This paper focuses on the aspects of test approval, test risk, test cycle, experimental equipment, research participants and review of research reports, etc. The differences between clinical trials of medical devices and clinical trials of drugs are summarized and the corresponding quality control countermeasures are put forward in order to provide a reference for hospitals planning to establish clinical trials of medical devices.
【作者单位】：南京医科大学第一附属医院临床医学研究院;南京医科大学第一附属医院科技处药物临床试验机构办公室;
【基金】：江苏省科技厅软科学项目(BR2014087)
【分类号】：R955

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