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MT-Keyboard:贝叶斯模型辅助的间隔设计,以考虑I期试验中的毒性等级和类型

Kai Chen¹, Li Wang², Ying Yuan³

¹Department of Biostatistics and Data Science, The University of Texas Health Science Center, Houston, TX, USA.

Statistics in biopharmaceutical research

|January 29, 2025

概括

这项研究介绍了MT-Keyboard设计,这是一种用于剂量发现试验的新贝叶斯方法. 它有效地结合了各种毒性等级和类型,改进了只关注严重毒性的传统方法.

科学领域:

临床试验临床试验
生物统计学生物统计学
瘤学药物开发药物开发

背景情况:

传统的剂量检测试验依赖于剂量限制性毒性 (DLT),通常缺乏新疗法的毒性.
定义为严重不良事件 (3级+) 的DLT,对于具有低毒性的向疗法和免疫疗法是不够的.
项目最佳化和ASA BIOP论坛强调需要在瘤学中改进剂量优化和选择.

研究的目的:

提出一种新的模型辅助贝叶斯设计,即MT键盘,用于剂量发现.
除了DLT之外,还要纳入各种毒性信息 (等级和类型).
为了扩大设计的晚发性毒性 (TITE-MT-键盘).

主要方法:

引入了多重毒性键盘 (MT-Keyboard) 的贝叶斯设计.
适应二进制,准二进制和持续毒性终点.
开发了TITE-MT-Keyboard扩展,用于使用近似概率进行晚发性毒性.

主要成果:

模拟显示了MT-Keyboard和TITE-MT-Keyboard的理想操作特性.
拟议的设计性能与现有方法相比或更好.
基于Web的软件可以在www.trialdesign.org.org上实现.

结论:

MT-Keyboard的设计提供了一种有效且易于实施的剂量发现方法.
这种设计提高了通过考虑多种等级和类型来表征药物毒性的能力.
TITE-MT-Keyboard扩展解决了临床试验中晚发性毒性的挑战.

关键词:

贝叶斯式设计贝叶斯式设计晚期发生的毒性.模型辅助设计模型辅助设计第一阶段试验试验.毒性等级有毒性等级有毒性类型有毒性类型

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