对于具有多个干预和生物标志物分层分配的主协议的共变适应性偏差硬币随机化,具有多个干预和生物标志物分层分配
Tianhao Song1, Lisa M LaVange1, Anastasia Ivanova1
1Department of Biostatistics, CB #7420, the University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599-7420, USA.
Statistics in biopharmaceutical research
|January 2, 2025
概括
本研究引入了对临床试验的偏见硬币设计,以改善干预分配. 它确保生物标志物阳性和生物标志物阴性参与者的所需比例被分配到特定的治疗.
科学领域:
- 临床试验 临床试验
- 生物统计学 生物统计学
- 基因组医学是基因组医学.
背景情况:
- 丰富临床试验手臂与生物标志物阳性参与者可以优化干预分配.
- 在具有子组的多臂试验中实现所需的分配比率是一个复杂的挑战.
研究的目的:
- 描述一个有偏见的硬币设计,以优化多臂试验中的干预分配.
- 为了实现所需的干预和生物标志物地位的分配比率在子组内.
主要方法:
- 实现一个有偏见的硬币随机化算法.
- 基于生物标志物状态和干预组的分层随机化.
- 在重症和/或易恶化的喘精确干预 (PrecISE) 试验中的应用.
主要成果:
- 偏见的硬币设计允许有针对性的注册生物标志物阳性个体.
- 在现实世界试验环境中证明了实现所需的分配比率.
- 根据参与者的生物标志物,促进有效和精确的干预分配.
结论:
- 偏差硬币设计提供了一种灵活的方法,以提高临床试验中的干预丰富性.
- 这种方法支持精确地针对特定的参与者子组进行干预.
- PrecISE试验证明了这种随机化策略的成功应用.
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