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在第三阶段临床试验中提高生物标志物种群的适应性扩张能力

Guoqing Diao1, Xun Jiang2, Donglin Zeng3

  • 1Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, George Washington University, Washington, District of Columbia, USA.

Journal of biopharmaceutical statistics
|March 20, 2025
PubMed
概括

这项研究引入了一个统一的生物标志物丰富设计,用于第三阶段临床试验. 这种新方法通过根据生物标志物状态调整招聘来提高试验成功率,并精确控制错误率.

关键词:
适应性设计适应性设计马丁盖尔 (Martingale) 是一个中间终点是中间的终点.预测性的生物标志物两个阶段的设计设计.

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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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