基于监管科学的临床试验机构质量风险可视化模型
A visualization model for the quality risk assessment of clinical trial institutions based on regulatory science
董文彬 1张雪梅 1陈一飞2
作者信息
- 1. 复旦大学药学院,上海 201203
- 2. 上海药品审评核查中心,上海 201203
- 折叠
摘要
药物临床试验机构是药物临床试验质量管理中的关键性角色,为保障药物临床试验质量发挥了重要作用.目前,行业各方均在积极探索科学的药物临床试验机构能力评价方式,但现有研究主要集中在对其建设水平的评价方面,对药物临床试验机构质量管理能力评价的研究关注度较低,研究尚需深入.本研究简要梳理了我国药物临床试验机构质量管理能力评价的学术研究现状,讨论了我国监管部门对药物临床试验机构进行评价的现有基础,并从药品监管科学的角度,以风险管理为切入点,基于相关法规文件,通过半定量分析方法,探索开发了药物临床试验机构质量风险可视化模型.
Abstract
Drug clinical trial institutions(GCP institutions)play a key role in clinical trials quality management(QM).At present,all sides of the industry are actively exploring scientific methods for GCP institution ability evaluation.But existing studies mainly focus on the construction level assessment of GCP institutions.While the research on the QM ability evaluation is still ignored or insufficient.In this work,we briefly reviewed the stadies for QM ability evaluation of GCP institutions,discussed the existing basis for the evaluation of GCP institutions by regulatory authorities.Furthermore,from the perspectives of drug regulatory science and risk management,based on relevant regulations,we also explored a visualization model for the quality risk assessment in GCP institutions by semi-quantitative analysis.
关键词
药品监管科学/药物临床试验机构/质量风险/可视化模型Key words
drug regulatory science/drug clinical trial institution/quality risk/visualization model引用本文复制引用
出版年
2024
NETL
NSTL
万方数据