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).
| Version: | 0.1.1 |
| Depends: | R (≥ 4.1.0) |
| Imports: | stats, ggplot2 (≥ 3.4.0) |
| Suggests: | testthat (≥ 3.0.0), knitr, rmarkdown |
| Published: | 2026-04-01 |
| DOI: | 10.32614/CRAN.package.SingleArmMRCT (may not be active yet) |
| Author: | Gosuke Homma [aut, cre] |
| Maintainer: | Gosuke Homma <my.name.is.gosuke at gmail.com> |
| BugReports: | https://github.com/gosukehommaEX/SingleArmMRCT/issues |
| License: | MIT + file LICENSE |
| URL: | https://gosukehommaEX.github.io/SingleArmMRCT/, https://github.com/gosukehommaEX/SingleArmMRCT |
| NeedsCompilation: | no |
| Language: | en-GB |
| Materials: | README, NEWS |
| CRAN checks: | SingleArmMRCT results |
| Package source: | SingleArmMRCT_0.1.1.tar.gz |
| Windows binaries: | r-devel: not available, r-release: not available, r-oldrel: not available |
| macOS binaries: | r-release (arm64): SingleArmMRCT_0.1.1.tgz, r-oldrel (arm64): not available, r-release (x86_64): not available, r-oldrel (x86_64): not available |
Please use the canonical form https://CRAN.R-project.org/package=SingleArmMRCT to link to this page.