在临床试验中实施包容性代表性的基于卡片的操作框架的设计
Marisa Minetti1, Ylenia Paleari2, Chiara Mazzoli2
1Chiesi Farmaceutici SpA, Parma, Italy. m.minetti@chiesi.com.
Trials
|February 24, 2026
概括
一个新的基于卡片的操作框架 (CBOF) 为制药公司提供了可操作的指导,以改善临床试验中的包容性代表性. 该框架解决了运营上的差距,增强了患者的多样性,并符合道德标准.
科学领域:
- 临床试验操作临床试验操作
- 卫生公平和包容性健康公平和包容性
- 制药研发领域的研究和开发.
背景情况:
- 临床试验中代表性招募的不一致实施仍在继续.
- 现有的框架缺乏具体指导,供赞助商在整个试验生命周期内嵌入包容性代表 (IR).
- 一个基于卡片的操作框架 (CBOF) 被开发来解决这些缺口.
研究的目的:
- 制定一个操作框架,使临床试验中的包容性代表 (IR) 成为可行的.
- 为制药公司提供可操作的工具和特定角色的指导,以嵌入IR.
- 将试验设计和组织实践与患者多样性的监管和伦理期望相协调.
主要方法:
- 一项四阶段的方法研究,包括范围审查,比较矩阵分析,专家咨询和使用5W1H结构的框架开发.
- 评估15个现有框架的运营完整性和缺陷的识别.
- 设计简报与来自监管,学术,患者倡导和制药部门的专家顾问委员会进行验证.
主要成果:
- CBOF是一个基于卡片的模块化工具集,分为九个IR类别,涵盖试验设计和组织准备.
- 包括核心卡,支持卡,349个实施策略和一个KPI目录,具体说明产品和试验生命周期中的责任,时间表和执行方法.
- 专家反证实了可用性和相关性,建议改进适应性和数字工具集成.
结论:
- CBOF将IR原则转化为对临床试验赞助商,特别是制药公司的结构化,可操作的指导.
- 它通过整合决策支持工具,角色委托和关键关键指标来解决运营上的差距.
- 代表了实现包容性试验设计和满足赞助商期望的实际进步,等待现实世界的验证.
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