Main Problems and Ethical Review Points of Subject Recruitment in Drug Clinical Trials
10.12026/j.issn.1001-8565.2023.01.04
- VernacularTitle:药物临床试验受试者招募的主要问题及伦理审查要点
- Author:
Lei ZHANG
1
;
Chunyi HAO
2
;
Jie LI
3
Author Information
1. Medical Ethics Committee, Beijing Cancer Hospital & Beijing Institute for Cancer Research, Key Laboratory of Carcinogenesis and Translational Research of Ministry of Education, Beijing 100142
2. Department of Gastrointestinal Oncology, Beijing Cancer Hospital, Beijing 100142, China
3. Department of Hepato Pancreato-Biliary Surgery, Beijing Cancer Hospital, Beijing 100142, China
- Publication Type:Journal Article
- Keywords:
Drug Clinical Trials;
Subject Recruitment;
Ethical Review;
Rights and Interests of Subjects
- From:
Chinese Medical Ethics
2023;36(1):22-26
- CountryChina
- Language:Chinese
-
Abstract:
Drug clinical trials need to recruit suitable subjects to verify the safety and effectiveness of new drugs. Subject recruitment is a very important and challenging link in the whole process of drug clinical trials, and even directly affects the progress and final results of the trials. The medical ethics committee should give full play to the important function of ethical review, carefully review the whole process of subject recruitment from the perspective of science and ethics, and do a good job in the protection of the health and rights of subjects. This paper mainly discussed the basic principles of subject recruitment, the main problems existing in the recruitment process and the key contents of ethical review, so as to provide scientific references and suggestions for standardizing subject recruitment, protecting the rights and interests of subjects, and promoting the efficient and high-quality completion of drug clinical trials.
