Exploration and Reflection on Improving the Efficiency and Quality of Ethical Review in Multi-center Clinical Trial
- VernacularTitle:提高多中心临床研究伦理审查效率和质量的探索及思考
- Author:
Jingjing WANG
1
;
Shizhi FAN
2
;
Xiangli LIAO
1
;
Hongyan DUAN
1
;
Jianwu ZHU
3
Author Information
1. Office of Ethics Committee，Daping Hospital of Army Medical University，Chongqing 400042，China
2. Dept. of Cardio-vascular Surgery，Daping Hospital of Army Medical University，Chongqing 400042，China
3. Medical Research Department，Daping Hospital of Army Medical University，Chongqing 400042，China
- Publication Type:Journal Article
- Keywords:
Multi-center clinical trial;
Ethical filling system;
Ethical review quality;
Ethical review efficiency
- From:
China Pharmacy
2019;30(23):3196-3199
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE： To explore the ways to improve the efficiency and quality of ethical review in multi-center clinical trial. METHODS： After issuing the policy of Opinions on Deepening the Reform of Approval System and Encouraging the Innovation of Pharmaceutical Medical Devices and Measures for the Administration of Drug Registration （Revised Version）， combined with the practice of our center， the methods to improve the efficiency and quality of ethical review， the possible problems of complete filling system and the way to improve the efficiency and quality of ethical review in multi-center clinical trial were analyzed in our center. RESULTS & CONCLUSIONS： Our center adopted a variety of review methods （conference review， rapid review， filing system， etc.）， implemented hierarchical management and differential review process for research projects， and formulated defined rules of filling system operation and other ways to improve the efficiency and quality of review， doubled the review efficiency， increased the number of follow-up review and field visit. In the process of exploration， the ethics committee of our center believes that the complete implementation of the filing system will lead to problems such as the difficulty to evaluate the quality of the ethical review of the leader unit， different research qualifications and conditions of each center， etc. In order to improve the efficiency and quality of the ethical review of multi-center clinical research， the measures are can be adopted， such as improving the quality of the ethical review of the center， strengthening the communication and mutual recognition of the ethics committees of each center， and establishing the preliminary review system of the secretary of the ethics committee， so as to realize the balance of efficiency and quality.
