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评估分层β-二项式模型作为篮子试验中的基本信息共享工具
Moritz Pohl1, Lukas D Sauer1, Meinhard Kieser1
1Institute of Medical Biometry, University of Heidelberg, Heidelberg, Germany.
Journal of biopharmaceutical statistics
|September 27, 2024
概括
与复杂的逻辑转换模型相比,分层β-二项式模型为篮子试验中的统计信息共享提供了一个更简单,更易于解释的替代方案.
科学领域:
- 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:
- 目前的篮子试验统计方法主要使用贝叶斯层次模型,具有逻辑转换的响应率.
- 这种逻辑转换使模型的解释和应用在临床环境中变得复杂.
研究的目的:
- 研究分层β-二项式模型作为在篮子试验中信息共享的逻辑转换模型的可行的替代方案.
- 系统地比较两种建模方法在临床试验设计中的适用性.
主要方法:
- 系统地比较分布假设和贝叶斯的行为贝塔二项式和逻辑转换模型.
- 制定一个校准程序,在模型中设置可比的先验值.
- 在模拟研究中推导一个评估指标来评估共享属性.
主要成果:
- 层次化的β-二项式模型展示了在篮子试验中共享信息的可行方法.
- 与逻辑转换模型相比,β-双项模型提供了更好的解释性.
- 开发了一种新的评估措施来评估共享财产.
结论:
- 层次化的β-二项式模型是在篮子试验中共享统计信息的可行且不那么复杂的替代方案.
- 这种方法提高了临床研究的利益相关者对模型的理解.
- 进一步采用β-双项模型可以简化篮子试验方法.
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