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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 + file LICENSE
URL: https://github.com/gosukehommaEX/bbssr
NeedsCompilation: no
Materials: NEWS
CRAN checks: bbssr results

Documentation:

Reference manual: 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: not available, r-oldrel: not available
macOS binaries: r-release (arm64): bbssr_1.0.2.tgz, r-oldrel (arm64): bbssr_1.0.2.tgz, r-release (x86_64): not available, r-oldrel (x86_64): not available

Linking:

Please use the canonical form https://CRAN.R-project.org/package=bbssr to link to this page.

These binaries (installable software) and packages are in development.
They may not be fully stable and should be used with caution. We make no claims about them.
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