Package: SingleArmMRCT 0.1.1

SingleArmMRCT: Regional Consistency Probability for Single-Arm Multi-Regional Clinical Trials

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).

Authors:Gosuke Homma [aut, cre]

SingleArmMRCT_0.1.1.tar.gz
SingleArmMRCT_0.1.1.zip(r-4.7)SingleArmMRCT_0.1.1.zip(r-4.6)SingleArmMRCT_0.1.1.zip(r-4.5)
SingleArmMRCT_0.1.1.tgz(r-4.6-any)SingleArmMRCT_0.1.1.tgz(r-4.5-any)
SingleArmMRCT_0.1.1.tar.gz(r-4.7-any)SingleArmMRCT_0.1.1.tar.gz(r-4.6-any)
SingleArmMRCT_0.1.1.tgz(r-4.6-emscripten)
manual.pdf |manual.html✨
DESCRIPTION |NEWS
card.svg |card.png
SingleArmMRCT/json (API)

# Install 'SingleArmMRCT' in R:
install.packages('SingleArmMRCT', repos = c('https://gosukehommaex.r-universe.dev', 'https://cloud.r-project.org'))

Bug tracker:https://github.com/gosukehommaex/singlearmmrct/issues

Pkgdown/docs site:https://gosukehommaex.github.io

On CRAN:

Conda:

binaryclinical-trialscontinuousnegative-binomialregional-consistencytime-to-event

4.48 score 179 downloads 12 exports 17 dependencies

Last updated from:809cad455a. Checks:9 OK. Indexed: yes.

TargetResultTimeFilesSyslog
linux-devel-x86_64OK143
source / vignettesOK179
linux-release-x86_64OK145
macos-release-arm64OK108
macos-oldrel-arm64OK85
windows-develOK99
windows-releaseOK110
windows-oldrelOK96
wasm-releaseOK121

Exports:plot_rcp1armBinaryplot_rcp1armContinuousplot_rcp1armCountplot_rcp1armHazardRatioplot_rcp1armMilestoneSurvivalplot_rcp1armRMSTrcp1armBinaryrcp1armContinuousrcp1armCountrcp1armHazardRatiorcp1armMilestoneSurvivalrcp1armRMST

Dependencies:clicpp11farverggplot2gluegtableisobandlabelinglifecycleR6RColorBrewerrlangS7scalesvctrsviridisLitewithr

Introduction to SingleArmMRCT
Background | Regional Consistency Probability | Method 1: Effect Retention Approach | Method 2: Simultaneous Positivity Approach | Package Structure | Common Parameters | Quick Start Example | Closed-form solution | Monte Carlo simulation | Visualisation | Further Reading | References
Rendered fromintroduction.Rmdusingknitr::rmarkdown

Last update: 2026-03-29
Started: 2026-03-28

Non-Survival Endpoints: Continuous, Binary, and Count
1. Continuous Endpoint | Statistical model | Consistency criteria | Example | Visualisation | 2. Binary Endpoint | 3. Count Endpoint (Negative Binomial) | Summary | References
Rendered fromnon-survival-endpoints.Rmdusingknitr::rmarkdown

Last update: 2026-03-29
Started: 2026-03-28

Survival Endpoints: Hazard Ratio, Milestone Survival, and RMST
Common trial design framework | 1. Hazard Ratio Endpoint | Statistical model | Consistency criteria | Example | Effect of dropout | Visualisation | 2. Milestone Survival Endpoint | 3. RMST Endpoint | Summary | References
Rendered fromsurvival-endpoints.Rmdusingknitr::rmarkdown

Last update: 2026-03-29
Started: 2026-03-28

Readme and manuals

Help Manual

Help pageTopics
Plot Regional Consistency Probability for Single-Arm MRCT (Binary Endpoint)plot_rcp1armBinary
Plot Regional Consistency Probability for Single-Arm MRCT (Continuous Endpoint)plot_rcp1armContinuous
Plot Regional Consistency Probability for Single-Arm MRCT (Count Endpoint)plot_rcp1armCount
Plot Regional Consistency Probability for Single-Arm MRCT (Hazard Ratio Endpoint)plot_rcp1armHazardRatio
Plot Regional Consistency Probability for Single-Arm MRCT (Milestone Survival Endpoint)plot_rcp1armMilestoneSurvival
Plot Regional Consistency Probability for Single-Arm MRCT (RMST Endpoint)plot_rcp1armRMST
Print Method for rcp1armBinary Objectsprint.rcp1armBinary
Print Method for rcp1armContinuous Objectsprint.rcp1armContinuous
Print Method for rcp1armCount Objectsprint.rcp1armCount
Print Method for rcp1armHazardRatio Objectsprint.rcp1armHazardRatio
Print Method for rcp1armMilestoneSurvival Objectsprint.rcp1armMilestoneSurvival
Print Method for rcp1armRMST Objectsprint.rcp1armRMST
Regional Consistency Probability for Single-Arm MRCT (Binary Endpoint)rcp1armBinary
Regional Consistency Probability for Single-Arm MRCT (Continuous Endpoint)rcp1armContinuous
Regional Consistency Probability for Single-Arm MRCT (Count Endpoint)rcp1armCount
Regional Consistency Probability for Single-Arm MRCT (Time-to-Event Endpoint)rcp1armHazardRatio
Regional Consistency Probability for Single-Arm MRCT (Milestone Survival Endpoint)rcp1armMilestoneSurvival
Regional Consistency Probability for Single-Arm MRCT (RMST Endpoint)rcp1armRMST