regional.consistency.probs: Calculate Regional Consistency Probabilities

In RegionalConsistency: Calculate Regional Consistency Probabilities for Multi-Regional Clinical Trials

Calculate Regional Consistency Probabilities

Description

This function calculates approximate regional consistency probabilities using Methods 1 and 2 proposed by Japanese MHLW (2007). The function can obtain:

• Unconditional regional consistency probabilities

• Joint regional consistency probabilities

• Conditional regional consistency probabilities

For technical details, please see Homma (2024)

Usage

regional.consistency.probs(f.s, PI, alpha, power, seed)

Arguments

f.s	A numeric vector representing the proportion of patients in region s(=1,...,S) among patients in the entire trial population. Values must sum to 1.
PI	A numeric value specifying the threshold for Method 1 (typically set at 0.5).
alpha	A numeric value representing the one-sided level of significance.
power	A numeric value representing the target power.
seed	A random number seed.

Value

A list containing the following components:

f.s

The input proportion of patients in each region

PI

The input threshold value for Method 1

alpha

The input one-sided significance level

power

The input target power

seed

The input seed number

Uncond.Method1

Unconditional regional consistency probability for Method 1

Joint.Method1

Joint regional consistency probability for Method 1

Cond.Method1

Conditional regional consistency probability for Method 1

Uncond.Method2

Unconditional regional consistency probability for Method 2

Joint.Method2

Joint regional consistency probability for Method 2

Cond.Method2

Conditional regional consistency probability for Method 2

Examples

regional.consistency.probs(
  f.s = c(0.1, 0.45, 0.45),
  PI = 0.5,
  alpha = 0.025,
  power = 0.8,
  seed = 123
)

RegionalConsistency documentation built on June 8, 2025, 10:11 a.m.