The Role and Positioning of Clinical Trial Ethics Review under Pharmaceutical Innovation Strategy
10.12026/j.issn.1001-8565.2023.02.11
- VernacularTitle:医药创新战略下临床试验伦理审查的角色与定位
- Author:
Zhonglin CHEN
1
;
Gan HE
2
;
Yu FENG
1
;
Huihui HAN
1
;
Yao YAO
1
;
Ning ZHENG
1
Author Information
1. Office of Ethics, Shanghai Chest Hospital/ Shanghai Chest Hospital of Shanghai Jiao Tong University, Shanghai 200030, China
2. School of Public Health, Shanghai Jiao Tong University Health Science Center, Shanghai 200025, China
- Publication Type:Journal Article
- Keywords:
Pharmaceutical Innovation Strategy;
Ethical Review;
Ethics Committee;
Clinical Trial
- From:
Chinese Medical Ethics
2023;36(2):180-185
- CountryChina
- Language:Chinese
-
Abstract:
Ethical review runs through the whole process of drug clinical trials, and is a critical step to ensure the rights and interests of subjects. This paper analyzed and discussed the role and positioning of ethical review in new drug clinical trials, cleared the principles of ethical review, identified the responsibilities of ethical review, and clarified the authority of ethical review approval documents. The ethical review should primarily focus on the ethics of the clinical trials, not replace other professional institutions to review the clinical trials’ legality and scientific nature. Ethical approval is only one of the necessary conditions for conducting clinical trials, not the only factor. It is recommended to strengthen the publicity and popularization of scientific and technological ethics awareness, improve the clinical trial approval mechanism, and optimize the phrasing of ethical review approval documents. It is warranted to further optimize the quality of ethical review, improve the construction of ethical review system, ultimately achieve the unity of promoting innovation and preventing risks, so as to effectively realize the benign interaction between high-quality development of scientific and technological innovation and high-level safety.
