Package: twoCoprimary 1.0.0

twoCoprimary: Sample Size and Power Calculation for Two Co-Primary Endpoints

Comprehensive functions to calculate sample size and power for clinical trials with two co-primary endpoints. The package supports five endpoint combinations: two continuous endpoints (Sozu et al. 2011 <doi:10.1080/10543406.2011.551329>), two binary endpoints using asymptotic methods (Sozu et al. 2010 <doi:10.1002/sim.3972>) and exact methods (Homma and Yoshida 2025 <doi:10.1177/09622802251368697>), mixed continuous and binary endpoints (Sozu et al. 2012 <doi:10.1002/bimj.201100221>), and mixed count and continuous endpoints (Homma and Yoshida 2024 <doi:10.1002/pst.2337>). All methods appropriately account for correlation between endpoints and provide both sample size and power calculation capabilities.

Authors:Gosuke Homma [aut, cre]

twoCoprimary_1.0.0.tar.gz
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twoCoprimary_1.0.0.tgz(r-4.6-emscripten)
manual.pdf |manual.html
DESCRIPTION |NEWS
card.svg |card.png
twoCoprimary/json (API)

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

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

Pkgdown/docs site:https://gosukehommaex.github.io

On CRAN:

Conda:

clinical-trialsco-primarypower-calculationsample-size-calculation

5.26 score 209 downloads 23 exports 3 dependencies

Last updated from:6c59c3bf42. Checks:9 OK. Indexed: yes.

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linux-devel-x86_64OK142
source / vignettesOK236
linux-release-x86_64OK138
macos-release-arm64OK80
macos-oldrel-arm64OK118
windows-develOK90
windows-releaseOK100
windows-oldrelOK88
wasm-releaseOK105

Exports:corrbound2Binarycorrbound2MixedCountContinuousdbibinomdesign_tablepower2BinaryApproxpower2BinaryExactpower2Continuouspower2MixedContinuousBinarypower2MixedCountContinuousrr1Binaryss1BinaryApproxss1Continuousss1Countss2BinaryApproxss2BinaryExactss2Continuousss2MixedContinuousBinaryss2MixedCountContinuoustwoCoprimary2BinaryApproxtwoCoprimary2BinaryExacttwoCoprimary2ContinuoustwoCoprimary2MixedContinuousBinarytwoCoprimary2MixedCountContinuous

Dependencies:fpComparemvtnormpbivnorm

Mixed Count and Continuous Co-Primary Endpoints
Overview | Background | Clinical Context | Why Negative Binomial Distribution? | Statistical Framework | Model and Assumptions | Correlation Structure | Hypothesis Testing | Test Statistics | Joint Distribution and Correlation | Power Calculation | Sample Size Determination | Correlation Bounds | Example: Calculate Correlation Bounds | Replicating Homma and Yoshida (2024) Table 1 (Case B) | Basic Usage Examples | Example 1: Balanced Design | Example 2: Effect of Correlation | Example 3: Effect of Dispersion Parameter | Example 4: Unbalanced Allocation | Power Verification | Practical Recommendations | Design Considerations | When to Use This Method | Challenges and Considerations | References

Last update: 2025-11-09
Started: 2025-11-02

Overview of Two Co-Primary Endpoints Analysis
Introduction | What are Co-Primary Endpoints? | Statistical Properties | Hypotheses Structure | Statistical Framework | Intersection-Union Test (IUT) | Type I Error Control | Overall Power | Impact of Correlation | Supported Endpoint Types | 1. Two Continuous Endpoints | 2. Two Binary Endpoints (Asymptotic Approximation) | 3. Two Binary Endpoints (Exact Methods) | 4. Mixed Continuous and Binary Endpoints | 5. Mixed Count and Continuous Endpoints | Why Does Correlation Matter? | Choosing the Right Method | Decision Guidelines | Sample Size Calculation Approach | Detailed Vignettes | References

Last update: 2025-11-09
Started: 2025-11-02

Two Binary Co-Primary Endpoints (Asymptotic Methods)
Overview | Background | Clinical Context | When to Use Asymptotic Methods | Statistical Framework | Model and Assumptions | Correlation Structure | Hypothesis Testing | Test Statistics | Method 1: Standard Normal Approximation (AN) | Method 2: Normal Approximation with Continuity Correction (ANc) | Method 3: Arcsine Transformation (AS) | Method 4: Arcsine Transformation with Continuity Correction (ASc) | Joint Distribution and Correlation | Power Calculation | Sample Size Calculation | Replicating Sozu et al. (2010) Table III | Key Findings | Basic Usage Examples | Example 1: Equal Effect Sizes | Example 2: Unequal Effect Sizes | Example 3: Effect of Correlation | Example 4: Unbalanced Allocation | Power Verification | Comparison of Test Methods | Practical Recommendations | Design Considerations | When to Use Exact Methods Instead | Asymptotic Validity | References

Last update: 2025-11-09
Started: 2025-11-02

Two Continuous Co-Primary Endpoints
Overview | Background and Motivation | What are Co-Primary Endpoints? | Clinical Examples | Statistical Framework | Model and Assumptions | Effect Size Parameterization | Hypothesis Testing | Test Statistics | Joint Distribution | Power Formula | Sample Size Calculation | Basic Example | Impact of Correlation | Visualization with plot() | Replicating Sozu et al. (2011) Table 1 | Power Calculation | Power for a Given Sample Size | Power Verification | Unified Interface | Unknown Variance Case | Practical Considerations | Correlation Estimation | Sensitivity Analysis | References

Last update: 2025-11-09
Started: 2025-11-02

Mixed Continuous and Binary Co-Primary Endpoints
Overview | Background | Clinical Context | Why Mixed Endpoints? | Statistical Framework | Model and Assumptions | Correlation Structure: Biserial Correlation | Hypothesis Testing | Test Statistics | Joint Distribution and Power Calculation | Sample Size Determination | Replicating Sozu et al. (2012) Table 2 | Replicating Sozu et al. (2012) Supporting Information Table 5 | Basic Usage Examples | Example 1: Balanced Design | Example 2: Effect of Correlation | Example 3: Comparison of Test Methods | Example 4: Unbalanced Allocation | Power Verification | Practical Recommendations | Design Considerations | When to Use This Method | Challenges and Considerations | References

Last update: 2025-11-09
Started: 2025-11-02

Two Binary Co-Primary Endpoints (Exact Methods)
Overview | Background | When to Use Exact Methods | Advantages of Exact Methods | Disadvantages | Statistical Framework | Model and Assumptions | Joint Distribution of Binary Outcomes | Number of Responders | Bivariate Binomial Distribution | Correlation Structure | Hypothesis Testing | Superiority Hypotheses | Co-Primary Endpoints (Intersection-Union Test) | Statistical Tests | Method 1: One-sided Pearson Chi-squared Test (Chisq) | Method 2: Fisher's Exact Test (Fisher) | Method 3: Fisher's Mid-P Test (Fisher-midP) | Method 4: Z-pooled Exact Unconditional Test (Z-pool) | Method 5: Boschloo's Exact Unconditional Test (Boschloo) | Exact Power Calculation | Power Formula | Sample Size Calculation | Replicating Homma and Yoshida (2025) Table 4 | Practical Examples | Example 1: Basic Exact Power Calculation | Example 2: Sample Size Calculation | Example 3: Comparison of Test Methods | Impact of Correlation | Example 4: Correlation Effect | Comparison: Exact vs Asymptotic | Example 5: Exact vs AN Method | Practical Recommendations | Test Method Selection | When to Use Each Method | Correlation Estimation | Allocation Ratio | Computational Considerations | Software Implementation | References

Last update: 2025-11-09
Started: 2025-11-02

Readme and manuals

Help Manual

Help pageTopics
Calculate Correlation Bounds Between Two Binary Outcomescorrbound2Binary
Calculate Correlation Bounds Between Count and Continuous Outcomescorrbound2MixedCountContinuous
Probability Mass Function of Bivariate Binomial Distributiondbibinom
Create Design Comparison Table for Two Co-Primary Endpointsdesign_table
Plot Method for twoCoprimary Objectsplot.twoCoprimary
Power Calculation for Two Co-Primary Binary Endpoints (Approximate)power2BinaryApprox
Exact Power Calculation for Two Co-Primary Binary Endpointspower2BinaryExact
Power Calculation for Two Co-Primary Continuous Endpointspower2Continuous
Power Calculation for Two Co-Primary Mixed Endpointspower2MixedContinuousBinary
Power Calculation for Two Co-Primary Endpoints (Count and Continuous)power2MixedCountContinuous
Print Method for twoCoprimary Objectsprint.twoCoprimary
Print Method for twoCoprimary_table Objectsprint.twoCoprimary_table
Rejection Region for Two-Arm Trials with a Single Binary Endpointrr1Binary
Sample Size Calculation for a Single Binary Endpointss1BinaryApprox
Sample Size Calculation for a Single Continuous Endpointss1Continuous
Sample Size Calculation for a Single Count Endpoint (Negative Binomial)ss1Count
Sample Size Calculation for Two Co-Primary Binary Endpoints (Asymptotic Approximation)ss2BinaryApprox
Exact Sample Size Calculation for Two Co-Primary Binary Endpointsss2BinaryExact
Sample Size Calculation for Two Co-Primary Continuous Endpoints (Approximate)ss2Continuous
Sample Size Calculation for Two Co-Primary Endpoints: One Continuous and One Binaryss2MixedContinuousBinary
Sample Size Calculation for Two Co-Primary Endpoints: One Count and One Continuousss2MixedCountContinuous
Unified Interface for Two Co-Primary Binary Endpoints (Approximate Methods)twoCoprimary2BinaryApprox
Unified Interface for Two Co-Primary Binary Endpoints (Exact Methods)twoCoprimary2BinaryExact
Unified Interface for Two Co-Primary Continuous EndpointstwoCoprimary2Continuous
Unified Interface for Mixed Continuous and Binary Co-Primary EndpointstwoCoprimary2MixedContinuousBinary
Unified Interface for Mixed Count and Continuous Co-Primary EndpointstwoCoprimary2MixedCountContinuous