在随机试验中,对复合的时间到事件终点的考克斯回归模型的性能与组件智能审查在随机试验中
Jaime Lynn Speiser1, Walter T Ambrosius1, Nicholas M Pajewski1
1Department of Biostatistics and Data Science, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Clinical trials (London, England)
|May 27, 2023
概括
考克斯回归模型在临床试验中对复合的时间到事件终点表现良好,即使组件的审查方法不同. 这一分析证实了它们对于大型研究中复杂的结果评估的适用性.
科学领域:
- 临床试验 临床试验
- 生物统计学 生物统计学
- 生存分析的分析.
背景情况:
- 在临床试验中,复合时间到事件终点对于评估多个相关结果非常有价值.
- 复合终点的组件可以有不同的审查机制 (例如,右与间隔审查).
- 在大型试验中,Cox回归模型与组件智能审查的性能尚未得到充分证实.
研究的目的:
- 调查考克斯回归模型对复合时间到事件终点的性能,并进行组件智能审查.
- 在各种审查场景下评估偏见,信任区间覆盖率和权力.
主要方法:
- 模拟数据具有不同的治疗结果关联和事件比例.
- 包括右边审查和间隔审查的组件.
- 结合间隔审查数据的比较方法 (上值与中点).
主要成果:
- 考克斯模型证明了在复合结果中检测治疗效应的足够能力,并进行了组件智能的审查.
- 在零假设下或当治疗效应在组件之间相似时,没有观察到实质偏差.
- 无论使用间隔审查数据的上值还是中点,模型性能都是一致的.
结论:
- 考克斯回归是一种合适的统计方法,用于分析临床试验数据,具有具有多种审查机制的复合时间到事件终点.
- 这些发现支持在具有复杂复合结果的PREVENTABLE等试验中使用考克斯模型.
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