Multiple Arm, Analysis

Gabriel Potvin and Anoop Singh Rawat

October 31, 2025

This example is related to the Integration Point: Analysis. Click the link for setup instructions, variable details, and additional information about this integration point.

To try this example, create a new project in East Horizon using the following configuration:

• Study objective: Multiple Arm Confirmatory
• Number of endpoints: Single Endpoint
• Endpoint type:
• Continuous Outcome for Example 1
• Binary Outcome for Example 2
• Task: Explore

Note: This example is compatible with both Fixed Sample and Group Sequential statistical designs. The R code automatically detects whether interim look information (LookInfo) is available and adjusts the analysis parameters accordingly.

Introduction

The following examples illustrate how to integrate new analysis capabilities into East Horizon using R functions in the context of multi-arm clinical trials. Each example demonstrates a different type of statistical endpoint (continuous, time-to-event, and binary), using standard R functions and a Bonferroni adjustment to handle multiple comparisons.

In the R directory of this example you will find the following R files:

1. AnalyzeMultiArmUsingTTestBonferroni.R - Performs pairwise t-tests for continuous endpoints with Bonferroni adjustment.

2. AnalyzeMultiArmUsingPropTestBonferroni.R - Performs proportion tests for binary endpoints with Bonferroni adjustment.

Example 1 - Using the t.test() Function with Bonferroni Adjustment (Continuous Outcome)

This example is related to this R file: AnalyzeMultiArmUsingTTestBonferroni.R

This example uses R’s built-in t.test() function to compare continuous outcomes between each treatment arm and the control arm. The function computes individual p-values for each comparison, applies a Bonferroni adjustment to control the family-wise error rate, and then checks whether any adjusted p-values cross the efficacy boundaries defined by East Horizon.

At each interim or final analysis, only active arms are tested (based on IsArmPresent). The analysis is compatible with both fixed and group sequential designs.

The figure below illustrates where this example fits within the R integration points of Cytel products, accompanied by a flowchart outlining the general steps performed by the R code.

Example 2 - Using the prop.test() Function with Bonferroni Adjustment (Binary Outcome)

This example is related to this R file: AnalyzeMultiArmUsingPropTestBonferroni.R

This example analyzes binary outcomes using R’s base prop.test() function. The test compares the proportion of responders in each treatment arm against the control arm, computes p-values for each test, and applies Bonferroni correction to account for multiple arms. Adjusted p-values are compared against efficacy boundaries to decide whether any arm demonstrates a statistically significant treatment effect.

The analysis dynamically accounts for dropped arms and adapts to both fixed and group sequential designs.

The figure below illustrates where this example fits within the R integration points of Cytel products, accompanied by a flowchart outlining the general steps performed by the R code.