Characteristic Analysis and Ethical Review Strategy of Medical Device Expanded Clinical Trials
10.12026/j.issn.1001-8565.2023.01.03
- VernacularTitle:医疗器械拓展性临床试验的特点分析及伦理审查策略
- Author:
Xinqing ZHAO
1
;
Mengjie YANG
1
;
Sijie WANG
1
;
Wenli QIAO
1
;
Xuening LI
1
Author Information
1. Medical Ethics Committee, Zhongshan Hospital, Shanghai 200032, China
- Publication Type:Journal Article
- Keywords:
Medical Devices;
Extended Clinical Trials;
Ethical Review;
Ethical Governance
- From:
Chinese Medical Ethics
2023;36(1):17-21
- CountryChina
- Language:Chinese
-
Abstract:
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.
