在使用随机中心效应的共变适应随机化下推断
Anjali Pandey1, Harsha Shree Bs1, Andrea Callegaro2
1Dev Biostats India Stats, GSK, Global Capability Center, Bengaluru, India.
Biometrical journal. Biometrische Zeitschrift
|September 23, 2025
概括
本研究介绍了一种随机效应模型,用于多中心试验中的共变量适应性随机化. 拟议的方法有效控制了I型错误,并保持了各种终点的统计能力.
科学领域:
- 临床试验方法论 临床试验方法论
- 生物统计学 生物统计学
- 统计建模 统计建模
背景情况:
- 在多中心试验中,最小化对于共变量适应性随机化很受欢迎.
- 包括分析控制中的最小化变量类型-I错误.
- 招聘中心是一个最小化变量,具有许多类别,经常被排除在模型之外.
研究的目的:
- 提出和评估一个随机效应模型,包括"中心"最小化变量.
- 为了评估这个模型对高斯,二进制和波桑终点变量的性能.
- 为灵敏度分析提供重新随机化测试的替代方案.
主要方法:
- 开发了一个统计模型,将"中心"变量作为随机效应.
- 使用高斯,二进制和波桑终点变量进行模拟研究.
- 在各种临床试验环境下评估I型错误控制和统计能力.
主要成果:
- 随机效应模型有效地控制了所有测试的终点类型中的I型错误.
- 对于高斯,二进制和波桑终点来说,保留了最大的统计功率.
- 拟议的模型在各种临床试验模拟中显示出强大的性能.
结论:
- 包括"中心"变量作为随机效应是共变量适应随机化的有效方法.
- 该方法为敏感性分析提供了重新随机化测试的可靠替代方案.
- 随机效应模型确保了多中心试验中的统计完整性和功率.
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