通过构建药物临床试验质量问题分类标准优化质量管理体系

Optimizing the quality management system by establishing classification criteria for quality control findings in drug clinical trials

摘要

目的: 构建科学合理的药物临床试验质量问题四级分类标准,用于优化临床试验质量管理体系。方法: 通过对临床试验的流程分析、风险评估与改进措施间的关系梳理,运用场景逆向验证方法,建立临床试验质量问题四级分类标准。结果: 四级分类标准实现了临床试验质量风险量化和多维度的比较,以及质量问题的精准根因分析与快速闭环的改进。结论: 优化后的质量管理体系能够高效识别临床试验质量核心风险,提升风险评估效率与整改效能。

Abstract

Objective: To construct a scientifically sound four-level classification system for quality control (QC) findings in drug clinical trials, in order to optimize the clinical trial quality management system. Methods: A four-level classification system was established by analyzing the clinical trial process, clarifying the relationship among risk assessment and improvement measures, and applying the scenario reverse verification method. Results: The four-level classification enabled the quantification and multi-dimensional comparison of clinical trial quality risks, as well as accurate root cause analysis of quality issues and rapid closed-loop improvement. Conclusion: The optimized quality management system can efficiently identify core risks in clinical trial quality and improve the efficiency of risk assessment and corrective actions.

关键词

临床试验 / 质量管理 / 质量问题分类标准

Key words

clinical trials / quality of management / classification of quality control findings

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基金资助

首都卫生发展科研专项资助项目(2022-2Z-2153);北自然-海淀原始创新联合基金资助项目(L232032);北京市属医院科研培育项目(PG2023018)