Package: SingleArmMRCT Type: Package Title: Regional Consistency Probability for Single-Arm Multi-Regional Clinical Trials Version: 0.1.1 Authors@R: person( given = "Gosuke", family = "Homma", role = c("aut", "cre"), email = "my.name.is.gosuke@gmail.com" ) 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). License: MIT + file LICENSE Encoding: UTF-8 Language: en-GB Roxygen: list(markdown = TRUE) RoxygenNote: 7.3.3 Depends: R (>= 4.1.0) Imports: stats, ggplot2 (>= 3.4.0) Suggests: testthat (>= 3.0.0), knitr, rmarkdown VignetteBuilder: knitr URL: https://gosukehommaEX.github.io/SingleArmMRCT/, https://github.com/gosukehommaEX/SingleArmMRCT BugReports: https://github.com/gosukehommaEX/SingleArmMRCT/issues Config/testthat/edition: 3 Repository: https://gosukehommaex.r-universe.dev Date/Publication: 2026-04-02 00:44:48 UTC RemoteUrl: https://github.com/gosukehommaex/singlearmmrct RemoteRef: HEAD RemoteSha: 809cad455aef032121357d04a3d20dcea3da9e93 NeedsCompilation: no Packaged: 2026-07-07 06:34:01 UTC; root Author: Gosuke Homma [aut, cre] Maintainer: Gosuke Homma