Background and objective: 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, to describe the event of a patient who experiences a dose-limiting toxicity. However, there is a growing interest in dose-finding studies involving 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, it still lacks accessible software to implement these methods. Methods: We introduce a newly developed R package, Unified Dose Finding, which implements three phase I dose-finding methods with non-binary outcomes by Yuan, et al. (2007) and Pan, et al. (2014) (Quasi-and Robust Quasi-CRM design), by Mu, et al. (2019) (gBOIN design), and by Ivanova, et al. (2009) (denoted by Ivanova design).Results: For each of the methods, Unified Dose Finding provides corresponding functions that begin with next_ to determine the dose for the next cohort of patients, begin with select_ to select the MTD defined by non-binary toxicity endpoint when the trial is completed, and begin with get_oc to obtain the operating characteristics. Conclusion:The R package Unified Dose Finding provides a user-friendly tool to facilitate the implementation of innovative dose-finding studies with non-binary outcomes.
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