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      • An R package UnifiedDoseFinding for continuous and ordinal outcomes in Phase I dose-finding trials

        Rongji Mu,Chia Wei Hsu,Shouhao Zhou,Haitao Pan 한국통계학회 2022 Communications for statistical applications and me Vol.29 No.4

        Phase I dose-finding trials are essential in drug development. By finding the maximum tolerated dose (MTD) of a new drug or treatment, a Phase I trial establishes the recommended doses for later-phase testing. The primary toxicity endpoint of interest is often a binary variable, which describes an event of a patient who experiences dose-limiting toxicity. However, there is a growing interest in dose-finding studies regarding non-binary outcomes, defined by either the weighted sum of rates of various toxicity grades or a continuous outcome. Although several novel methods have been proposed in the literature, accessible software is still lacking to implement these methods. This study introduces a newly developed R package, UnifiedDoseFinding, which implements three phase I dose-finding methods with non-binary outcomes (Quasi- and Robust Quasi-CRM designs by Yuan it et al. (2007) and Pan it et al. (2014), gBOIN design by Mu it et al.(2019), and by a method by Ivanova and Kim (2009)). For each of the methods, UnifiedDoseFinding provides corresponding functions that begin with next_ that determines the dose for the next cohort of patients, select\_, which selects the MTD defined by the non-binary toxicity endpoint when the trial is completed, and get_oc, which obtains the operating characteristics. Three real examples are provided to help practitioners use these methods. The R package UnifiedDoseFinding, which is accessible in R CRAN, provides a user-friendly tool to facilitate the implementation of innovative dose-finding studies with nonbinary outcomes.

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