医疗器械拓展性临床试验的特点分析及伦理审查策略

Characteristic Analysis and Ethical Review Strategy of Medical Device Expanded Clinical Trials

拓展性临床试验是基于人道主义,为没有其他有效医疗手段可延长生命或减轻痛苦的特定患者提供在临床试验过程中的新医疗产品的医疗救治活动,同时具备医疗和科研属性,与注册临床试验显著不同,需要特殊的伦理关注。目前中国的拓展性临床试验尚处于起步阶段,法律法规和配套管理办法不够完善,也缺乏对该类特殊临床试验的伦理治理经验。以医疗器械拓展性临床试验为例,参考国内外目前的法律法规,分析其特点,并对中国医疗器械拓展性临床试验的受理阶段特殊关注、初审与批准的策略及跟踪审查策略提出全流程伦理治理建议。

Extended clinical trials are medical treatment activity based on the humanitarianism to provide new medical products during the clinical trials for specific patients who have no other effective medical means to prolong life or alleviate pain.Extensive clinical trials have both medical and scientific attributes,which are significantly different from registered clinical trials and require special ethical attention.At present,the extended clinical trials in China are still in the initial stage,laws,regulations and supporting management methods are not perfect,and there is a lack of experience in ethical governance of such special clinical trials.This paper took the expanded clinical trial of medical devices as an example,referred to the current laws and regulations at home and abroad,analyzed their characteristics,and put forward some suggestions on the ethical governance of the whole process of the expanded clinical trials of medical devices in China,including special concerns in the application and acceptance,the first review approval strategy and the key points in continuing review.