针对多组临床试验的响应适应性随机化,使用上下文依赖信息措施
Ksenia Kasianova1, Mark Kelbert1, Pavel Mozgunov2
1Faculty of Economics, National Research University Higher School of Economics, Moscow, Russia.
Biometrical journal. Biometrische Zeitschrift
|October 10, 2023
概括
这项研究将随机化引入基于的临床试验设计,平衡统计能力和患者数量. 区块随机化调整可以提高功率,但不会显著影响预期成功次数 (ENS).
科学领域:
- 临床试验 临床试验
- 生物统计学 生物统计学
- 决策理论 决策理论
背景情况:
- 在临床试验设计中,理论信息方法在平衡统计能力和预期成功数量 (ENS) 方面具有优势.
- 内置的重量函数参数有助于实现小人群II期试验所需的权衡.
- 随机设计在现实世界的临床试验中是首选的.
研究的目的:
- 将随机化引入到基于确定性的顺序试验程序中,用于多臂设置.
- 对基于的设计应用的各种随机化方法的统计能力和ENS进行调查.
主要方法:
- 考虑了四种设计类型:确定性,天真随机化,块随机化和随机惩罚参数.
- 基于的随机设计与随机的吉丁斯指数 (GI) 和固定随机化 (FR) 进行了比较.
- 进行了全面的模拟研究,以评估设计性能.
主要成果:
- 基于和基于GI的区块随机化显示,对于足够的统计能力来说,随机化不足.
- 对前性程序的调整显著改善了功率,对ENS的影响最小.
- 随机惩罚参数程序的属性被彻底调查.
结论:
- 区块随机化需要调整以增强基于和基于GI的设计中的统计能力.
- 拟议的调整提供了一种有效的方法来提高随机临床试验中的功率.
- 随机惩罚参数设计需要进一步研究它们的特性.
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