NEWS

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twoCoprimary 1.0.0 (2025-11-21)

Initial Release

This is the first release of twoCoprimary, providing comprehensive tools for sample size and power calculation in clinical trials with two co-primary endpoints.

Features

• Two Continuous Endpoints

  • ss2Continuous(), power2Continuous(), twoCoprimary2Continuous()
  • Based on Sozu et al. (2011)
  • Supports known and unknown variance cases

• Two Binary Endpoints (Asymptotic Methods)

  • ss2BinaryApprox(), power2BinaryApprox(), twoCoprimary2BinaryApprox()
  • Based on Sozu et al. (2010)
  • Four test methods: AN, ANc, AS, ASc

• Two Binary Endpoints (Exact Methods)

  • ss2BinaryExact(), power2BinaryExact(), twoCoprimary2BinaryExact()
  • Based on Homma and Yoshida (2025)
  • Five exact tests: Chisq, Fisher, Fisher-midP, Z-pool, Boschloo

• Mixed Continuous and Binary Endpoints

  • ss2MixedContinuousBinary(), power2MixedContinuousBinary(), twoCoprimary2MixedContinuousBinary()
  • Based on Sozu et al. (2012)
  • Supports biserial correlation structure

• Mixed Count and Continuous Endpoints

  • ss2MixedCountContinuous(), power2MixedCountContinuous(), twoCoprimary2MixedCountContinuous()
  • Based on Homma and Yoshida (2024)
  • Handles overdispersed count data with negative binomial distribution

Utility Functions

• corrbound2Binary() - Calculate valid correlation bounds for binary endpoints
• corrbound2MixedCountContinuous() - Calculate valid correlation bounds for count and continuous endpoints
• design_table() - Create comprehensive design comparison tables
• plot.twoCoprimary() - Visualize sample size vs correlation relationships

Documentation

• Six comprehensive vignettes covering all methodologies
• Complete function documentation with examples
• Validation against published results

Testing

• Comprehensive test suite with testthat
• Tests for all major functions
• Validation against published tables and results