Study on Quality Risk Management of Ethical Review of Dr ug Clin ical Trials
- VernacularTitle:药物临床试验伦理审查质量风险的管理研究
- Author:
Hao YU
1
;
Yan PAN
1
;
Zhi’ang WU
1
,
2
;
Wei XUE
3
;
Kexin LI
3
Author Information
1. School of Business Administration，Shenyang Pharmaceutical University，Shenyang 110016，China
2. Beijing Yidu Zhengkang Health Technology Co.，Ltd.，Beijing 100055，China
3. Beijing Hospit al Clinical Trial Center，Beijing 100083，China
- Publication Type:Journal Article
- Keywords:
Drug clinical trials;
Ethical review;
Risk manag ement;
Analytic hierarchy process;
Expert opinion method
- From:
China Pharmacy
2020;31(10):1153-1157
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE：To pro vide suggestions for imp roving the quality of ethical review of drug clinical trials in China and protecting the rights and interests of subjects. METHODS ：Guided by risk management theory ，the literature research method ， expert opinion method and analytic hierarchy process method were used to sort out the ethical review process of drug clinical trials ， extract and determine the risk factors that affect the quality of ethical review ，and determine the weight of each risk factor. Suggestions were put forward improving the ethical review of drug clinical trials in China. RESULTS & CONCLUSIONS ： Established ethical review risk index system of drug clinical trials included 31 influential factors of 5 aspects；the order of importance（weights）of 5 aspects affecting the quality of ethical review of drug clinical trials was as follows ：the construction of the medical ethics committee （0.263 5），the management of review meetings （0.251 4），follow-up review （0.194 5），the acceptance and processing of review applications （0.189 2），and the management of documents and files （0.101 4）. The influential factors with high weight included “withdrawal of people with conflict of interest in the discussion and voting process （0.078 7）” “timely review or conference discussion of scheme modification ，informed consent modification ，serious adverse events ，etc. （0.070 5）”“clarification and external exhibition of the work process and time of ethical review （0.059 8）”“unified and standardized review standards and approval standards （0.052 1）”，etc. The quality of ethical review can be improved by avoiding people with conflict of interest in the discussion and voting process ，timely reviewing or holding ethics meetings on scheme modification ， informed consent modification ，serious adverse events ，etc.，clarifying the working process and time of ethical review ，and establishing unified and standardized review standards and approval standards.
