UnifiedDoseFinding: 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) <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.

Version: 0.1.10
Published: 2022-10-15
Author: Chia-Wei Hsu, Haitao Pan, Rongji Mu
Maintainer: Chia-Wei Hsu <Chia-Wei.Hsu at stjude.org>
License: GPL-2
NeedsCompilation: no
In views: ClinicalTrials, Pharmacokinetics
CRAN checks: UnifiedDoseFinding results

Documentation:

Reference manual: UnifiedDoseFinding.pdf

Downloads:

Package source: UnifiedDoseFinding_0.1.10.tar.gz
Windows binaries: r-devel: UnifiedDoseFinding_0.1.10.zip, r-release: UnifiedDoseFinding_0.1.10.zip, r-oldrel: UnifiedDoseFinding_0.1.10.zip
macOS binaries: r-release (arm64): UnifiedDoseFinding_0.1.10.tgz, r-oldrel (arm64): UnifiedDoseFinding_0.1.10.tgz, r-release (x86_64): UnifiedDoseFinding_0.1.10.tgz
Old sources: UnifiedDoseFinding archive

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