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Phase I clinical trials in adoptive T-cell therapies
The Journal of the Royal Statistical Society: Series C (Applied Statistics) ( IF 1.6 ) Pub Date : 2021-03-29 , DOI: 10.1111/rssc.12485
Sean M Devlin 1 , Alexia Iasonos 1 , John O'Quigley 2
Affiliation  

We develop three approaches to phase I dose finding designs for engineered T cells in oncology. Our goal is to address a very particular difficulty in this clinical setting: an inability to fully administer the dose allocated to some patients. Current designs can be biased as a result of this incomplete information being ignored or discarded from the analysis. The performance of the three proposed solutions is largely similar, and all offer an advantage over the currently used design. One of the three methods is supported by theoretical study, and we provide some new results on this approach.

中文翻译:

过继性 T 细胞疗法的 I 期临床试验

我们为肿瘤学中的工程化 T 细胞开发了三种 I 期剂量发现设计方法。我们的目标是解决这种临床环境中的一个非常特殊的困难:无法完全管理分配给某些患者的剂量。由于这些不完整的信息被忽略或从分析中丢弃,当前的设计可能会出现偏差。三种提议的解决方案的性能非常相似,并且都比当前使用的设计具有优势。三种方法中的一种得到了理论研究的支持,我们在这种方法上提供了一些新的结果。
更新日期:2021-03-29
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