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
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: not available, 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:

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