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bbssr: Blinded Sample Size Re-Estimation for Binary Endpoints

Provides comprehensive tools for blinded sample size re-estimation (BSSR) in two-arm clinical trials with binary endpoints. Unlike traditional fixed-sample designs, BSSR allows adaptive sample size adjustments during trials while maintaining statistical integrity and study blinding. Implements five exact statistical tests: Pearson chi-squared, Fisher exact, Fisher mid-p, Z-pooled exact unconditional, and Boschloo exact unconditional tests. Supports restricted, unrestricted, and weighted BSSR approaches with exact Type I error control. Statistical methods based on Mehrotra et al. (2003) <doi:10.1111/1541-0420.00051> and Kieser (2020) <doi:10.1007/978-3-030-49528-2_21>.

Version:1.0.2
Depends:R (≥ 3.5.0)
Imports:fpCompare, stats
Suggests:testthat (≥ 3.0.0),knitr,rmarkdown,dplyr,ggplot2,tibble,tidyr,Exact,exact2x2,microbenchmark
Published:2025-06-18
DOI:10.32614/CRAN.package.bbssr
Author:Gosuke Homma [aut, cre]
Maintainer:Gosuke Homma <my.name.is.gosuke at gmail.com>
BugReports:https://github.com/gosukehommaEX/bbssr/issues
License:MIT + fileLICENSE
URL:https://github.com/gosukehommaEX/bbssr
NeedsCompilation:no
Materials:NEWS
CRAN checks:bbssr results

Documentation:

Reference manual:bbssr.html ,bbssr.pdf
Vignettes:Introduction to bbssr: Blinded Sample Size Re-estimation for Binary Endpoints (source,R code)
Statistical Methods in bbssr (source,R code)
Validation of bbssr Package Functions (source,R code)

Downloads:

Package source: bbssr_1.0.2.tar.gz
Windows binaries: r-devel:bbssr_1.0.2.zip, r-release:bbssr_1.0.2.zip, r-oldrel:bbssr_1.0.2.zip
macOS binaries: r-release (arm64):bbssr_1.0.2.tgz, r-oldrel (arm64):bbssr_1.0.2.tgz, r-release (x86_64):bbssr_1.0.2.tgz, r-oldrel (x86_64):bbssr_1.0.2.tgz

Linking:

Please use the canonical formhttps://CRAN.R-project.org/package=bbssrto link to this page.


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