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将共变量纳入替代悖论的测量方法中的风险
Fatema Shafie Khorassani1, Jeremy M G Taylor1, Niko Kaciroti1
1Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI 48109, USA.
概括
本研究引入了评估临床试验中代孕悖论风险的方法,其中治疗对代孕和真实终点的影响可能有所不同. 结合共变量有助于预测和减轻这种悖论.
科学领域:
- 生物统计学 生物统计学
- 临床试验 临床试验
- 流行病学 流行病学
背景情况:
- 临床试验经常使用代用终点,这是预期预测临床益处的措施,但可能并不总是与真实终点保持一致.
- 一个"代孕悖论"发生在治疗影响代孕和真正的终点在相反的方向,尽管他们的相关性.
研究的目的:
- 通过结合共变量信息,开发评估代孕悖论风险的方法.
- 量化对代理治疗对真实终点相反治疗效应的概率.
- 确定与共变量调整的替代终点治疗效应如何影响负面真终点效应的风险.
主要方法:
- 使用元分析因果关联框架.
- 制定措施来计算治疗对代用终点和真终点产生相反影响的概率.
- 模拟替代终点治疗效应与真实终点风险之间的关系,作为共变量的函数.
主要成果:
- 拟议的方法允许将共变量纳入评估代理悖论风险的过程中.
- 该框架量化了相反治疗效应的概率.
- 为了减少负面的真实终点效应风险所需的积极代用终点治疗效应的大小是作为共变量的函数来确定的.
结论:
- 可以将共变量信息整合到评估代理悖论风险的措施中.
- 开发的方法为了解和减轻临床试验分析中代孕悖论提供了定量方法.
- 这一框架适应了不同试验的不同共变量效应.
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