多重对比测试的样本大小规划
Anna Pöhlmann1, Frank Konietschke1
1Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Biometry and Clinical Epidemiology, Berlin, Germany.
Biometrical journal. Biometrische Zeitschrift
|September 5, 2023
概括
本研究为使用多重对比测试的多样样样本临床前研究引入了新的样本大小计算方法. 这些准确,易于使用的工具改善了与多个样本的临床试验的规划.
科学领域:
- 生物统计学 生物统计学
- 临床前研究 临床前研究
- 临床试验设计 临床试验设计
背景情况:
- 已建立的样本大小计算存在于临床研究中的两个独立样本.
- 在临床前研究中常见的多个样本的样本大小规划存在挑战.
- 现有的方法通常使用难以解释效应大小的方差分析 (ANOVA).
研究的目的:
- 开发和验证在临床前研究中用于多个样本的样本大小计算方法.
- 采用多重对比测试程序,以便更易于解释的样本大小规划.
- 提供准确和易于使用的工具,用于多个样本的临床试验设计.
主要方法:
- 使用多重对比测试程序进行样本大小计算.
- 使用钢型试验对参数 (正常性假设) 和非参数设计应用方法.
- 由于未知分布和缺乏闭式公式,使用了近似解决方案和数值近似.
主要成果:
- 为多个样本开发了准确的样本大小计算方法.
- 模拟研究证实,这些方法实现了检测替代品的目标功率.
- 建议的程序是有效的规划前临床和临床试验,多个样本.
结论:
- 开发的基于多重对比测试的样本大小计算是准确和可靠的.
- 这些方法为研究人员提供了一种有价值的工具,他们计划使用多个样本进行临床前和临床试验.
- 这些程序可以通过公开可用的软件访问,从而促进它们的广泛采用.
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