论文标题

剂量查找试验进行药物组合的早期完成

Data-Dependent Early Completion of Dose Finding Trials for Drug-Combination

论文作者

Kojima, Masahiro

论文摘要

我们提出了一个依赖于数据的剂量发现试验的药物组合试验的早期完成。当通过试验数据剂量保留剂量的β-二项式概率并且剩余患者的数量很高时,可以确定早期完成。本文还提出了一种早期完成方法,即通过双变量等渗回归来调整剂量保留概率。我们证明了虚拟试验的早期完成。我们通过使用12个方案的模拟研究评估了早期完成方法的性能。我们确认了我们提出的早期完成方法的出色表现。我们显示了在试验开始之前确定早期完成的患者数量以及本文计算剂量保留概率的程序代码。

We propose a data-dependent early completion of dose finding trials for drug-combination. The early completion is determined when a beta-binomial probability for dose retainment with the trial data and the number of remaining patients is high. This paper also proposes an early completion method that a dose retainment probability is adjusted by a bivariate isotonic regression. We demonstrate the early completion for a virtual trial. We evaluate the performance of early completion method through simulation studies with 12 scenarios. We confirmed the superior performance for our proposed early completion methods. We show the number of patients for determining early completion before a trial starts and a program code for calculating dose retainment probability in this paper.

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