Challenges， countermeasures， and key points of ethics review in investigator-initiated clinical trials of unlisted products
10.12026/j.issn.1001-8565.2025.01.05
- VernacularTitle:研究者发起的未上市产品临床研究的挑战、对策和伦理审查要点
- Author:
Honglei NIAN
1
;
Jihong LI
1
;
Jiyin ZHOU
2
Author Information
1. Office of Ethics Committee， Beijing Shijitan Hospital， Capital Medical University， Beijing 100038， China
2. Clinical Medical Research Center， the Second Affiliated Hospital of Army Medical University， Chongqing 400037， China
- Publication Type:Journal Article
- Keywords:
investigator-initiated clinical trial;
unlisted product;
ethical review;
ethics committee
- From:
Chinese Medical Ethics
2025;38(1):31-39
- CountryChina
- Language:Chinese
-
Abstract:
Investigator-initiated clinical trials （IIT） are an important part of scientific and technological activities involving human study participants. Among them， high-quality IIT can be used to support the marketing and registration application of drugs， medical devices， and other products when conditions permit. Currently， there is a huge gap between IIT and industry-initiated clinical trials. The use of unlisted products in IIT has problems， such as lack of regulatory support， insufficient research funding support， the need to improve the ability of clinical research management departments， the weakness of professional clinical research teams， and the difficulty of ethics review to match the demands. The challenges could be addressed by improving regulations and conducting pilot trials on a small scale， guaranteeing adequate research funding， strengthening the construction of clinical research management systems， building professional clinical research teams， ensuring the quality of ethical reviews and strict follow-up reviews， shifting from ethical reviews to a system for protecting research participants， and reinforcing training for researchers. Ethics committees should strictly review key points， such as the risk-benefit ratio， informed consent， research funding， compensation for damages， qualifications and equipment of research team members， and management of conflict of interest.
