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SingleArmMRCT
View on CRAN: Click
here
Download and install SingleArmMRCT package within the R console
Install from CRAN:
install.packages("SingleArmMRCT")
Install from Github:
library("remotes")
install_github("cran/SingleArmMRCT") Install by package version:
library("remotes")
install_version("SingleArmMRCT", "0.1.1") Attach the package and use:
library("SingleArmMRCT")
Maintained by
Gosuke Homma
[Scholar Profile | Author Map]
[Scholar Profile | Author Map]
All associated links for this package
First Published: 2026-04-01
Latest Update: 2026-04-01
Description:
Provides functions to calculate and visualise the Regional Consistency Probability (RCP) for single-arm multi-regional clinical trials (MRCTs) using the Effect Retention Approach (ERA). Six endpoint types are supported: continuous, binary, count (negative binomial), time-to-event via hazard ratio, milestone survival, and restricted mean survival time (RMST). For each endpoint, both a closed-form (or semi-analytical) solution and a Monte Carlo simulation approach are implemented. Two consistency evaluation methods are available: Method 1 (effect retention in Region 1 relative to the overall population) and Method 2 (simultaneous positive effect across all regions). Plotting functions generate faceted visualisations of RCP as a function of the regional allocation proportion, overlaying formula and simulation results for direct comparison. The methodology follows the Japanese MHLW guidelines for MRCTs. Abbreviations used: RCP (Regional Consistency Probability), MRCT (Multi-Regional Clinical Trial), RMST (Restricted Mean Survival Time), MHLW (Ministry of Health, Labour and Welfare).
How to cite:
Gosuke Homma (2026). SingleArmMRCT: Regional Consistency Probability for Single-Arm Multi-Regional Clinical Trials. R package version 0.1.1, https://cran.r-project.org/web/packages/SingleArmMRCT. Accessed 25 Oct. 2026.
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