Exploration and practice of constructing a risk-based quality management model for clinical trials
10.3760/cma.j.cn113565-20220809-00141
- VernacularTitle:构建临床试验基于风险的质量管理模式的初步实践
- Author:
Zhiying FU
1
;
Shuhua ZHAO
;
Xiaohong LIU
;
Yannan YUAN
;
Min JIANG
Author Information
1. 北京大学肿瘤医院暨北京市肿瘤防治研究所 国家药物临床试验机构 恶性肿瘤发病机制及转化研究教育部重点实验室，北京 100142
- Keywords:
Clinical trials;
Risk;
Quality management
- From:
Chinese Journal of Medical Science Research Management
2022;35(5):379-384
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To conduct a quantitative and qualitative analysis of the issues found in quality management, establish a risk-based whole-process quality management model, and improve the quality of clinical trials.Methods:Based on the risk-based quality management theory, the issues found in the quality control of drug clinical trials in Beijing Cancer Hospital in 2020 were structured and classified by severity (mild to moderate to severe) and 10 categories, and the risk matrix was graded by a semi-quantitative method. Targeted quality control strategies for different levels of risk were carried out according to visual analysis of the informative quality analysis platform. Chi-square tests of the severity of quality control issues in our hospital in 2020 and 2021 and non-parametric tests of the number of issues per capita in each category were used to evaluate the effectiveness of the management model.Results:A risk matrix was established according to the severity and frequency of the issues found in the quality control in 2020. The issues with severe risks were categorized as protocol compliance and serious adverse events, and categories with moderate risks included informed consent, biological sample related, original records, and investigator folders. After using visual analysis and adopting the risk-based quality control strategy, the proportion of severe issues found in quality control in our hospital in 2021 was 0.92%, lower than that of 1.39% in 2020, and the difference was statistically significant. The average number of issues detected per capita in each category for each trial in 2021 was lower than that in 2020 with a statistical difference, indicating that the management model was effective.Conclusions:Using information technology to adopt risk-based quality management is helpful to improve the quality of hospital clinical trials.
