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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:
For technical details about the methodology, please refer to Homma (2024).
You can install the development version of RegionalConsistency from GitHub with:
# install.packages("devtools")
devtools::install_github("gosukehommaEX/RegionalConsistency")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)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.
These binaries (installable software) and packages are in development.
They may not be fully stable and should be used with caution. We make no claims about them.
Health stats visible at Monitor.