bbssr1.0.2 package

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>.

Useful links

• https://github.com/gosukehommaEX/bbssr/issues
• https://github.com/gosukehommaEX/bbssr