Package: bbssr 1.0.2

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>.

Authors:Gosuke Homma [aut, cre]

bbssr_1.0.2.tar.gz
bbssr_1.0.2.zip(r-4.7-any)bbssr_1.0.2.zip(r-4.6-any)bbssr_1.0.2.zip(r-4.5-any)
bbssr_1.0.2.tgz(r-4.6-any)bbssr_1.0.2.tgz(r-4.5-any)
bbssr_1.0.2.tar.gz(r-4.7-any)bbssr_1.0.2.tar.gz(r-4.6-any)
bbssr_1.0.2.tgz(r-4.6-emscripten)
manual.pdf |manual.html
DESCRIPTION |NEWS
card.svg |card.png
bbssr/json (API)

# Install 'bbssr' in R:
install.packages('bbssr', repos = c('https://gosukehommaex.r-universe.dev', 'https://cloud.r-project.org'))

Bug tracker:https://github.com/gosukehommaex/bbssr/issues

On CRAN:

Conda:

binary-endpointsclinical-trialspower-calculationsample-size-calculation

4.80 score 2 stars 21 scripts 268 downloads 4 exports 1 dependencies

Last updated from:e7021ecf08. Checks:9 OK. Indexed: yes.

TargetResultTimeFilesSyslog
linux-devel-x86_64OK129
source / vignettesOK251
linux-release-x86_64OK128
macos-release-arm64OK88
macos-oldrel-arm64OK79
windows-develOK69
windows-releaseOK77
windows-oldrelOK82
wasm-releaseOK113

Exports:BinaryPowerBinaryPowerBSSRBinaryRRBinarySampleSize

Dependencies:fpCompare

Validation of bbssr Package Functions
Introduction | Validation of BinaryPower Function | Test Parameters | Quick Verification Example | 1. Pearson Chi-squared Test | 2. Fisher Exact Test | 3. Fisher Mid-p Test | 4. Z-pooled Exact Unconditional Test | 5. Boschloo Exact Unconditional Test | Performance Comparison | Enhanced Computational Speed Benchmarks | BinaryPower Performance Comparison | Performance Visualization | Speed Improvement Summary | Summary of Validation Results | Accuracy Validation | Performance Improvements | Key Advantages of bbssr | Conclusion | Session Information

Last update: 2025-06-17
Started: 2025-06-14

Introduction to bbssr: Blinded Sample Size Re-estimation for Binary Endpoints
Introduction | What is Blinded Sample Size Re-estimation? | Key Advantages of BSSR | Getting Started | Basic Usage | Power Calculation for Traditional Design | Sample Size Calculation | Blinded Sample Size Re-estimation (BSSR) | Basic BSSR Example | Comparing BSSR Design Rules | Understanding the Results | Design Rule Comparison | Key Observations | Statistical Tests Available | Test Comparison Example | Practical Considerations | When to Use BSSR | Design Choice Guidelines | Next Steps

Last update: 2025-06-14
Started: 2025-06-13

Statistical Methods in bbssr
Introduction | Theoretical Foundation of BSSR | The Problem with Fixed Sample Sizes | The BSSR Solution | Mathematical Framework | Exact Statistical Tests | 1. Pearson Chi-squared Test ('Chisq') | 2. Fisher Exact Test ('Fisher') | 3. Fisher Mid-p Test ('Fisher-midP') | 4. Z-pooled Exact Unconditional Test ('Z-pool') | 5. Boschloo Exact Unconditional Test ('Boschloo') | Mathematical Relationships | Test Comparison | BSSR Methodology | Design Approaches | 1. Restricted Design (restricted = TRUE) | 2. Unrestricted Design (restricted = FALSE) | 3. Weighted Design (weighted = TRUE) | BSSR Implementation Example | Power Calculations | Traditional vs BSSR Power | Practical Implementation Guidelines | Choosing the Right Test | Choosing the BSSR Approach | Sample Size Planning | Regulatory Considerations | Type I Error Control | Documentation Requirements | Advanced Topics | Multiple Allocation Ratios | Sensitivity Analysis | Conclusion

Last update: 2025-06-14
Started: 2025-06-13