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在两阶段的临床设计中,使用多个生物标志物来丰富患者

Fengqing Zhang¹, Jiangtao Gou²

¹Department of Psychological and Brain Sciences, Drexel University, Philadelphia, PA 19104, United States of America.

Contemporary clinical trials

|August 10, 2025

概括

这项研究为临床试验引入了新的两阶段丰富设计,使得多种生物标志物的使用能够精确地识别可能从治疗中受益的患者群体. 这通过提高试验效率和准确性来推进精准医学.

科学领域:

临床试验设计临床试验设计
生物统计学生物统计学
药物基因组学药物基因组学

背景情况:

丰富策略对于精准医学至关重要,它针对生物标志物定义的种群来提高临床试验的效率和降低成本.
目前的两级丰富设计仅限于单个连续生物标志物,阻碍了多个预测标志物的整合.
结合多个生物标志物可以提高目标人群的识别准确性,但在值确定方面存在挑战.

研究的目的:

为临床试验提出新的两阶段丰富设计,可以容纳两个或两个以上的连续生物标志物.
为将多种生物标志物整合到试验设计中提供灵活的框架,增强精准医学方法.
为了应对在丰富设计中确定多个连续生物标志物的多个值的挑战.

主要方法:

为多个连续生物标志物开发一种新的两阶段丰富设计框架.
适应两个治疗效果指标:平均治疗效果 (ATE) 和标准化的ATE.
模拟研究评估第一阶段样本大小对值估计的影响.

主要成果:

拟议的设计为在临床试验中整合多个连续生物标志物提供了更大的灵活性.
该研究提供了一种方法来克服单个生物标志物丰富设计的局限性.
值估计被证明受试验第一阶段的样本大小的影响.

结论:

新的两阶段丰富设计有效处理多个连续生物标志物,推进临床试验方法.
这些设计提供了更大的灵活性和更高的准确性,用于确定针对性治疗的患者子组.
这些发现为优化精密医学研究中的丰富策略提供了有价值的见解.

关键词:

丰富临床试验的临床试验实验设计实验设计多个生物标志物.精准医学是一门精准的医学.门估计估计的门值.

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