BOP2FE: Bayesian Optimal Phase II Design with Futility and Efficacy Stopping Boundaries

Bayesian optimal design with futility and efficacy stopping boundaries (BOP2-FE) is a novel statistical framework for single-arm Phase II clinical trials. It enables early termination for efficacy when interim data are promising, while explicitly controlling Type I and Type II error rates. The design supports a variety of endpoint structures, including single binary endpoints, nested endpoints, co-primary endpoints, and joint monitoring of efficacy and toxicity. The package provides tools for enumerating stopping boundaries prior to trial initiation and for conducting simulation studies to evaluate the design’s operating characteristics. Users can flexibly specify design parameters to suit their specific applications. For methodological details, refer to Xu et al. (2025) <doi:10.1080/10543406.2025.2558142>.

Version: 1.0.3
Imports: gridExtra, patchwork, ggplot2, stats, utils
Suggests: spelling
Published: 2025-09-29
DOI: 10.32614/CRAN.package.BOP2FE (may not be active yet)
Author: Belay Birlie Yimer [aut, cre], Xinling Xu [aut], Atsuki Hashimoto [aut], Gosuke Homma [aut], Kentaro Takeda [aut]
Maintainer: Belay Birlie Yimer <belayabyimer at gmail.com>
BugReports: https://github.com/belayb/BOP2FE/issues
License: MIT + file LICENSE
URL: https://github.com/belayb/BOP2FE
NeedsCompilation: no
Language: en-US
Materials: README, NEWS
CRAN checks: BOP2FE results

Documentation:

Reference manual: BOP2FE.html , BOP2FE.pdf

Downloads:

Package source: BOP2FE_1.0.3.tar.gz
Windows binaries: r-devel: not available, r-release: not available, r-oldrel: not available
macOS binaries: r-release (arm64): not available, r-oldrel (arm64): not available, r-release (x86_64): BOP2FE_1.0.3.tgz, r-oldrel (x86_64): BOP2FE_1.0.3.tgz

Linking:

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