UnifiedDoseFinding

In many phase I trials, the design goal is to find the dose associated with a certain target toxicity rate. In some trials, the goal can be to find the dose with a certain weighted sum of rates of various toxicity grades. For others, the goal is to find the dose with a certain mean value of a continuous response. This package provides the setup and calculations needed to run a dose-finding trial with non-binary endpoints and performs simulations to assess design’s operating characteristics under various scenarios. Three dose finding designs are included in this package: unified phase I design (Ivanova et al. (2009) doi:10.1111/j.1541-0420.2008.01045.x), Quasi-CRM/Robust-Quasi-CRM (Yuan et al. (2007) doi:10.1111/j.1541-0420.2006.00666.x, Pan et al. (2014) doi:10.1371/journal.pone.0098147) and generalized BOIN design (Mu et al. (2018) doi:10.1111/rssc.12263). The toxicity endpoints can be handled with these functions including equivalent toxicity score (ETS), total toxicity burden (TTB), general continuous toxicity endpoints, with incorporating ordinal grade toxicity information into dose-finding procedure. These functions allow customization of design characteristics to vary sample size, cohort sizes, target dose-limiting toxicity (DLT) rates, discrete or continuous toxicity score, and incorporate safety and/or stopping rules.