在临床试验中的样本大小选择,当人口平均值受到部分顺序的约束时:单边的有序替代品
Bahadur Singh1, Susan Halabi2, Michael J Schell3
1Lineberger Comprehensive Cancer Center-UNC, Chapel Hill, NC, USA.
Journal of applied statistics
|June 20, 2025
概括
这项研究简化了对受限顺序数据的复杂统计方法. 它提供了一种新的临床试验样本大小计算方法,使用订购替代品将所需的参与者减少高达24%.
科学领域:
- 统计 统计 统计 统计
- 生物统计学 生物统计学
- 临床试验设计 临床试验设计
背景情况:
- 顺序受限的统计方法在数学上是复杂的.
- 在订单限制下进行概率比测试对于正常理论应用至关重要.
- 现有的方法缺乏可访问的解释和高效的计算算法.
研究的目的:
- 提供订单限制概率测试的方法背景.
- 描述订单受限估计和p值计算的算法.
- 提出一种新的两步程序,用于在订单限制下确定临床试验样本大小.
主要方法:
- 对于正常理论案例的订单限制概率测试的解释.
- 开发用于计算订单受限估计和p值的算法.
- 用指定最小功率 (0.80或0.90) 和顺序限制的正常平均值进行样本大小计算的两步程序.
主要成果:
- 建议的方法在使用单面订单替代品时,可将临床试验样本大小减少14-24% .
- 通过几个实践示例来证明方法的有效性.
- 订单限制估计和p值的简化计算.
结论:
- 开发的统计方法和算法增强了对数据分析中的订单限制的理解和应用.
- 新的样本大小确定程序在临床试验设计中提供了显著的效率提升.
- 这项工作有助于在受限顺序假设下进行更实用和资源高效的临床试验.
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