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Updated: Sep 13, 2025

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一个灵活无的2/3阶段设计,具有生物标记驱动的子组丰富和样本大小重新估计.

Zizhong Tian1, Liwen Wu2, Rachael Liu2

  • 1Department of Public Health Sciences, The Pennsylvania State University, Hershey, Pennsylvania, USA.

Pharmaceutical statistics
|August 1, 2025
PubMed
概括

这项研究引入了一种灵活的无2/3相适应设计,用于药物开发. 它优化了样本大小,并使用替代终点来提高效率和功率,特别是在患者子组.

关键词:
适应性设计是适应性的设计.对样本大小进行重新估计.无的2/3阶段设计.小组的丰富设计设计.替代终点 替代终点

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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
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