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构建临床试验基于风险的质量管理模式的初步实践

Exploration and practice of constructing a risk-based quality management model for clinical trials
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摘要 目的对质量管理发现的问题进行定量与定性分析, 以基于风险的全流程质量管理模式, 提高临床试验质量。方法运用基于风险的质量管理理论, 对2020年北京肿瘤医院药物临床试验质量控制发现的问题进行结构化, 按照问题严重程度(轻、中、重)和10种类别进行划分, 应用半定量法进行风险矩阵分级。根据信息化质量分析平台可视化分析对不同等级风险进行针对性质控策略。对2020年和2021年北京大学肿瘤医院质控项目的问题严重程度进行卡方检验, 各类别的人均问题数进行非参数检验, 评价该管理模式效果。结果根据2020年质控发现问题的严重程度及发生频率建立风险矩阵, 识别出存在高危风险的问题分类为方案依从及严重不良事件, 存在中危风险的类别包括知情同意、生物样本相关、原始记录及研究者文件夹。利用可视化分析、采取基于风险的质控策略后, 2021年医院质控发现的重度问题占比为0.92%, 较2020年1.39%下降, 差异有统计学意义。2021年各项目的各类别人均问题检出数较2020年质控项目的人均问题检出数低, 比较有统计学差异, 提示该管理模式有效。结论利用信息化技术采取基于风险的质量管理, 有助于提高医院临床试验质量。 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.
作者 傅志英 赵淑华 刘晓红 袁延楠 江旻 Fu Zhiying;Zhao Shuhua;Liu Xiaohong;Yuan Yannan;Jiang Min(Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education),National Drug Clinical Trial Center,Beijing Caner Hospital&Beijing Institute for Cancer Research,Beijing 100142,China)
出处 《中华医学科研管理杂志》 2022年第5期379-384,共6页 Chinese Journal of Medical Science Research Management
基金 首都卫生发展科研专项基金(首发课题:2022-27-2153) 北京市医院管理中心培育计划(PG20231103)。
关键词 临床试验 风险 质量管理 Clinical trials Risk Quality management
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