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临床试验中的响应适应性随机化:从神话到实际考虑

David S Robertson¹, Kim May Lee², Boryana C López-Kolkovska³

¹MRC Biostatistics Unit, University of Cambridge, Forvie Site, Robinson Way, Cambridge CB2 0SR, United Kingdom.

Statistical science : a review journal of the Institute of Mathematical Statistics

|June 16, 2023

概括

响应自适应随机化 (RAR) 调整了临床试验中的患者分配,基于传入的数据. 这一综述统一了对RAR的不同观点.

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
机器学习机器学习

背景情况:

响应适应随机化 (RAR) 是一种数据依赖的抽样方法.
自20世纪30年代以来,它在生物统计学和临床试验方面有着悠久的历史.
由于实践示例和机器学习应用,RAR已重新引起人们的兴趣.

研究的目的:

为提供响应适应随机化 (RAR) 的统一审查.
解决关于RAR有用性的不同观点的协调差距.
讨论临床试验中RAR的方法和实践考虑.

主要方法:

对RAR的生物统计和方法论文献的综述.
综合了RAR在临床试验中的应用的不同观点.
探索围绕RAR的实际和理论问题.

主要成果:

确定了对RAR的统一视角的需要.
突出了关于RAR的实用性和实施的持续辩论.
综合了关于RAR的好处和挑战的各种观点.

结论:

在临床试验方法学中,RAR仍然是引发重大辩论的主题.
对RAR的方法论和实践方面的全面了解至关重要.
这一综述提供了一个新的视角,以告知RAR在临床研究中的作用的讨论.

关键词:

伦理学伦理伦理学患者分配患者分配权力,权力,权力,权力.样本大小的不平衡时间趋势时间趋势我类型的错误控制控制.

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