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bbssr  

Blinded Sample Size Re-Estimation for Binary Endpoints
View on CRAN: Click here


Download and install bbssr package within the R console
Install from CRAN:
install.packages("bbssr")

Install from Github:
library("remotes")
install_github("cran/bbssr")

Install by package version:
library("remotes")
install_version("bbssr", "1.0.2")



Attach the package and use:
library("bbssr")
Maintained by
Gosuke Homma
[Scholar Profile | Author Map]
All associated links for this package
First Published: 2025-06-18
Latest Update: 2025-06-18
Description:
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>.
How to cite:
Gosuke Homma (2025). bbssr: Blinded Sample Size Re-Estimation for Binary Endpoints. R package version 1.0.2, https://cran.r-project.org/web/packages/bbssr. Accessed 06 Jun. 2026.
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