临床试验资格的螺旋测量值:紧急重新评估时间
Idan Bokobza1,2,3, Melanie Le Sayec2,4, Cara Bossley2,4
1National Heart and Lung Institute, Imperial College London, London, UK.
Thorax
|September 4, 2025
概括
对临床试验资格的转换螺旋测量方程影响了患者的准入. 新的GLI-Global方程式可能会排除700多名个人,因此需要对公平获取的试验门进行审查.
科学领域:
- 肺部医学
- 临床试验设计
- 螺旋测量标准
背景情况:
- 呼吸学临床试验通常使用基于种族取决于GLI-2012方程的百分比预测的1秒强迫呼气量 (ppFEV1) 值在40%至90%之间.
- 国际指导方针现在推了新的"种族中立"GLI-Global螺旋测量参考方程.
研究的目的:
- 量化从GLI-2012过渡到GLI-Global方程对呼吸学临床试验资格的影响.
- 评估患者在英国囊性纤维化注册表中的获取效果.
主要方法:
- 来自英国囊性纤维化注册表 (n=8182) 的螺旋测量数据分析.
- 使用GLI-2012和GLI-Global方程计算的ppFEV1值的比较.
- 根据新的方程,模拟90%ppFEV1资格门的影响.
主要成果:
- 转向GLI-Global方程式,特别是90%的ppFEV1上限,将使700多人成为新的不合格.
- 这一变化突显了基于螺旋测量方程选择的试验获取的潜在差异.
结论:
- 通过采用GLI-Global方程,迫切需要对临床试验资格中的固定ppFEV1值进行审查.
- 一个初步的建议是将ppFEV1资格范围扩大到30-95%,以确保跨民族的平等获取.
- 为了促进包容性,需要对参与试验的固定ppFEV1限值进行更广泛的重新评估.
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