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Design of Trials with Composite Endpoints with the R Package CompAREdesign
Jordi Cortés-Martínez1, Marta Bofill-Roig1,2, Guadalupe Gómez-Melis1
1Research group in Biostatistics and Bioinformatics, GRBIO, Department of Statistics and Operations Research and Institute for Research and Innovation in Health (IRIS), Universitat Politècnica de Catalunya (BarcelonaTech), Jordi Girona 1-3, 08034 Barcelona, Spain.
Statistics in Biosciences
|June 8, 2026
Summary
This study introduces CompAREdesign, an R package for designing clinical trials with composite endpoints. It addresses challenges like the proportional hazards assumption violation, offering novel methods for sample size and effect size calculations.
Area of Science:
- Clinical Trials Methodology
- Biostatistics
- Statistical Software Development
Background:
- Composite endpoints are common in time-to-event clinical trials.
- Proportional hazards assumption violations complicate trial design and sample size calculations.
- Existing statistical software often lacks specific tools for composite endpoint trial design.
Purpose of the Study:
- Introduce the R package CompAREdesign for clinical trial design.
- Provide novel methodologies for sample size and effect size computation for composite endpoints.
- Facilitate the design of trials with binary composite endpoints and offer simulation capabilities.
Main Methods:
- Development of the R package CompAREdesign.
- Incorporation of novel methodologies for composite endpoint trial design.
- Implementation of functions for sample size, effect size calculation, and trial simulation.
Main Results:
- CompAREdesign offers solutions for designing clinical trials with composite endpoints.
- The package calculates key design elements based on component endpoint information.
- It supports the design of trials with binary composite endpoints and includes simulation tools.
Conclusions:
- CompAREdesign is the first R package specifically for the design phase of clinical trials with composite endpoints.
- The package addresses critical design challenges, including proportional hazards assumption violations.
- CompAREdesign is available on CRAN, providing a valuable tool for researchers.
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