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).
Versions across snapshots
| Version | Repository | File | Size |
|---|---|---|---|
0.1.1 |
rolling linux/jammy R-4.5 | SingleArmMRCT_0.1.1.tar.gz |
284.7 KiB |
0.1.1 |
rolling linux/noble R-4.5 | SingleArmMRCT_0.1.1.tar.gz |
284.6 KiB |
0.1.1 |
rolling source/ R- | SingleArmMRCT_0.1.1.tar.gz |
147.6 KiB |
0.1.1 |
latest linux/jammy R-4.5 | SingleArmMRCT_0.1.1.tar.gz |
284.7 KiB |
0.1.1 |
latest linux/noble R-4.5 | SingleArmMRCT_0.1.1.tar.gz |
284.6 KiB |
0.1.1 |
latest source/ R- | SingleArmMRCT_0.1.1.tar.gz |
147.6 KiB |
0.1.1 |
2026-04-26 source/ R- | SingleArmMRCT_0.1.1.tar.gz |
147.6 KiB |
0.1.1 |
2026-04-23 source/ R- | SingleArmMRCT_0.1.1.tar.gz |
147.6 KiB |
0.1.1 |
2026-04-09 windows/windows R-4.5 | SingleArmMRCT_0.1.1.zip |
291.6 KiB |