Dose-Finding Methods for Non-Binary Outcomes

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) ), Quasi-CRM/Robust-Quasi-CRM (Yuan et al. (2007) , Pan et al. (2014) ) and generalized BOIN design (Mu et al. (2018) ). 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.


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0.1.8 by Chia-Wei Hsu, 6 months ago

Browse source code at

Authors: Chia-Wei Hsu , Haitao Pan , Rongji Mu

Documentation:   PDF Manual  

Task views: Clinical Trial Design, Monitoring, and Analysis

GPL-2 license

See at CRAN