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

02/09/2022

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by   Masahiro Kojima, et al.

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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.