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.
翻译:我们建议根据数据及早完成药物合并的剂量检测试验。当试验数据和剩余病人数量中剂量留存的乙型双胞胎概率较高时,即可确定早期完成。本文还提出早期完成方法,即剂量留存概率通过双变异同质回归调整。我们展示了虚拟试验的早期完成率。我们通过模拟研究对12个假想进行早期完成方法的绩效评估。我们确认了我们提议的早期完成方法的优异性能。我们显示了在试验开始前确定早期完成的患者人数,以及本文中计算剂量留存概率的程序代码。