Analysis and Discussion on the Ethical Pre-review Model of Clinical Trials under the Pharmaceutical Innovation Strategy
10.12026/j.issn.1001-8565.2022.11.08
- VernacularTitle:医药创新战略下临床试验的伦理审查前置模式分析与讨论
- Author:
Zhonglin CHEN
1
;
Gan HE
2
;
Yu FENG
1
;
Huihui HAN
1
;
Yao YAO
1
;
Ning ZHENG
1
Author Information
1. Clinical Research Center,Shanghai Chest Hospital, Shanghai 200030, China
2. School of Public Health, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
- Publication Type:Journal Article
- Keywords:
Ethical Pre-review;
Ethics Committee;
Clinical Trial;
Review Efficiency
- From:
Chinese Medical Ethics
2022;35(11):1214-1217
- CountryChina
- Language:Chinese
-
Abstract:
With the implementation of the national biomedical innovation strategy, new requirements for ethical review of clinical trials have been put forward, and more attention has been paid to the ethical pre-review. Based on the current situation of clinical trials and ethical review of new drugs in China, this paper discussed the concept, advantages and necessity of ethical pre-review, sorted out the problems and challenges in the implementation of ethical pre-review at this stage, and put forward the following suggestions on how to better implement ethical pre-review in clinical trials under the pharmaceutical innovation strategy: the complete definition of "ethical pre-review" should be made clearly; ethical review should be carried out on the basis of necessary reference; the scope of application of ethical pre-review should be clarified; after the ethical pre-review, the statement of the approval document should be standardized and accurate.
