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用精确方法计算二进制终点的顺序平行比较设计的样本大小

Guogen Shan¹, Yahui Zhang¹

¹Department of Biostatistics, University of Florida, Gainesville, FL, USA.

Journal of applied statistics

|February 14, 2025

概括

较高的安慰剂反应可能会破坏药物试验. 本研究引入了一种精确的条件方法来计算顺序并行比较设计 (SPCD) 中的样本大小,提高了小到中型样本大小和极端响应率的可靠性.

科学领域:

临床试验设计临床试验设计
生物统计学生物统计学
药学研究药学研究

背景情况:

临床试验中的高安慰剂反应可以掩盖真正的药物疗效,可能导致有前途的药物候选人失败.
顺序并行比较设计 (SPCD) 是一种用于减轻高安慰剂反应影响的策略.
目前用于SPCD二进制结果的统计方法通常依赖于非对称分布,在小到中型样本大小中表现不佳.

研究的目的:

提出SPCD中样本大小计算的准确条件方法,以解决非对称方法的局限性.
确保在临床试验样本大小确定无条件框架下对I型错误率进行可靠的控制.
用SPCD和随机并行研究的现有方法来比较精确样本大小的性能.

主要方法:

开发了一个精确的条件方法来计算样本大小.
利用现有的测试统计数据来订购精确计算的样本空间.
将拟议的精确样本大小与从非对称方法和标准随机并行设计中获得的样本大小进行了比较.

主要成果:

提出的精确条件方法有效控制了I型错误率.
精确的样本大小计算显示出高于非对称方法的性能,特别是对于小到中型样本大小.
该方法还建议用于SPCD场景,涉及极端响应率.

结论:

精确条件方法为SPCD的样本大小计算提供了更可靠的方法,特别是在处理有限的参与者数量或不寻常的响应率时.
这种方法提高了使用SPCD的临床试验的统计学严谨性,从而增加了准确评估药物有效性的可能性.
建议在SPCD中采用精确的样本大小,用于中小样本大小和极端响应率场景.

关键词:

62K0505 这是一本书.62L05 这是一个很好的例子.二进制终点二进制终点准确的方法准确的方法.据报道,安慰剂反应与安慰剂反应.连续并行比较设计的设计.

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