适应性平台试验中非并发控制的分析:分离随机和非随机信息
Ian C Marschner1, I Manjula Schou1
1NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
Biometrical journal. Biometrische Zeitschrift
|August 6, 2024
概括
适应性平台试验可以在非并发的对照中引入偏差. 一种新的队列调整方法,与时间调整不同,有效地消除了这种偏差,提高了试验效率和可靠性.
科学领域:
- 临床试验方法论 临床试验方法论
- 生物统计学 生物统计学
- 药学研究 药学研究
背景情况:
- 适应性平台试验可以实现动态治疗臂的修改,这可能导致对照组比实验臂更长时间活跃.
- 这导致非并发的控制,虽然提供了潜在的效率提升,但可以引入因时间混和其他因素而导致的偏差.
- 目前用于控制非并发控制中的混现有方法通常依赖于时间段调整.
研究的目的:
- 为了证明时间调整的局限性,在适应性平台试验中减轻来自非并发控制的偏差.
- 提出和验证一个更一般的分析框架,使用队列调整来准确考虑非并发的控制.
- 为分离随机和非随机治疗效果组件提供一种方法.
主要方法:
- 定义非并发对照,使用并发随机队列的概念.
- 员工队列调整作为时间调整的替代方案,用于分析自适应平台试验的数据.
- 利用模拟研究来比较时间调整与队列调整分析的性能.
- 通过网络元分析的透视来解释队列调整分析,以合成随机和间接的比较.
主要成果:
- 经过时间调整的分析被证明是不充分的,并且在存在非并发的控制时可能存在偏差.
- 群组调整分析有效地消除了非并发控制带来的偏差.
- 队列调整方法允许分离和评估随机和间接治疗效应组件之间的一致性.
结论:
- 时间调整不足以防止与非并发控制器的自适应平台试验中的偏差.
- 队列调整为处理非并发控制提供了强大的分析框架,提高了自适应平台试验的可靠性.
- 在使用非并发对照时,对治疗效果的分离随机和间接贡献的呈现至关重要.
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