RegionalConsistency

Overview

RegionalConsistency is an R package that calculates approximate regional consistency probabilities for multi-regional clinical trials using methods proposed by the Japanese Ministry of Health, Labor and Welfare (2007). The package implements both Method 1 and Method 2 approaches and can calculate:

1. Unconditional regional consistency probabilities
2. Joint regional consistency probabilities
3. Conditional regional consistency probabilities

For technical details about the methodology, please refer to Homma (2024).

Installation

# CRAN version 
install.packages("RegionalConsistency")

# Development version from GitHub
# install.packages("devtools")
devtools::install_github("gosukehommaEX/RegionalConsistency")

Usage

library(RegionalConsistency)

# Calculate regional consistency probabilities
result <- regional.consistency.probs(
  f.s = c(0.1, 0.45, 0.45),  # Proportion of patients in each region
  PI = 0.5,                  # Threshold for Method 1
  alpha = 0.025,             # One-sided significance level
  power = 0.8,               # Target power
  seed = 123                 # Seed for reproducibility
)

# View results
print(result)

References

Homma, G. (2024). Cautionary note on regional consistency evaluation in multi-regional clinical trials with binary outcomes. Pharmaceutical Statistics, https://doi.org/10.1002/pst.2358.

Ministry of Health, Labor and Welfare (2007). Basic principles on global clinical trials, https://www.pmda.go.jp/files/000153265.pdf.