过继性T细胞疗法的I期临床试验。
Phase I clinical trials in adoptive T-cell therapies.
作者信息
Devlin Sean M, Iasonos Alexia, O'Quigley John
机构信息
Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Department of Statistical Science, University College London, London, UK.
出版信息
J R Stat Soc Ser C Appl Stat. 2021 Aug;70(4):815-834. doi: 10.1111/rssc.12485. Epub 2021 Mar 29.
Abstract
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.
摘要
我们开发了三种用于肿瘤学中工程化T细胞I期剂量探索设计的方法。我们的目标是解决这种临床环境中一个非常特殊的难题：无法将分配给某些患者的剂量完全给药。由于这种不完整信息在分析中被忽略或丢弃，当前的设计可能会产生偏差。所提出的三种解决方案的性能在很大程度上相似，并且都比目前使用的设计具有优势。这三种方法中的一种得到了理论研究的支持，并且我们提供了关于这种方法的一些新结果。
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