Research Software |

CompAREdesign

Mon, 01 Jan 0001 00:00:00 +0000

Overview

CompAREdesign is an open-source R package developed to support the design of randomized clinical trials with composite endpoints. The package provides statistical methods for determining sample size and effect size under realistic scenarios where conventional design formulae may not be appropriate.

The package was developed to bridge methodological research and practical trial design, offering researchers flexible tools for planning studies involving both time-to-event and binary composite endpoints. :contentReference[oaicite:0]{index=0}

Main Features

Sample size calculation for composite time-to-event endpoints.
Design of trials with binary composite endpoints.
Sensitivity analyses under different assumptions.
Evaluation of alternative trial design scenarios.
Simulation tools for assessing design performance.

Publication

The methodology and the package are described in:

Cortés J, Bofill Roig M, Gómez G. Design of Trials with Composite Endpoints with the R Package CompAREdesign. Stat Biosci. 2026;18(2):395-417. doi: 10.1007/s12561-025-09488-3. Epub 2025 May 15

Availability

CRAN:
Vignettes: ,
Documentation:
Article:

Motivation

Composite endpoints are increasingly used in clinical research, but they introduce methodological challenges because the proportional hazards assumption often does not hold for the composite outcome, even when it does for its individual components. CompAREdesign provides practical tools to address these challenges and to support more reliable trial planning. :contentReference[oaicite:2]{index=2}

MSMpred

Mon, 01 Jan 0001 00:00:00 +0000

Overview

MSMpred is an interactive web application that facilitates the development, validation and interpretation of multistate models for predicting the individual evolution of patients over time.

The application was designed to make advanced multistate modelling accessible to clinicians and researchers without requiring programming expertise, providing an intuitive interface for model fitting, prediction and visualization. :contentReference[oaicite:1]{index=1}

Main Features

Interactive fitting of multistate models.
Individual prediction of disease progression.
Estimation of transition probabilities.
Dynamic visualization of patient trajectories.
User-friendly interface for applied researchers.

Applications

MSMpred is particularly useful in diseases where patients progress through different clinical stages over time. Although initially motivated by multiple sclerosis, the methodology is applicable to many chronic diseases and other longitudinal clinical settings. :contentReference[oaicite:2]{index=2}

Publication

Garmendia Bergés L, Cortés Martínez J, Gómez Melis G, et al. MSMpred: interactive modelling and prediction of individual evolution via multistate models. BMC Medical Research Methodology, 2023. :contentReference[oaicite:3]{index=3}

Availability

Web application (add link)
GitHub (add link)
Documentation (add link)
Publication:

Impact

MSMpred aims to bridge the gap between advanced statistical methodology and clinical practice by providing an accessible environment for multistate modelling. The application promotes reproducible analyses and helps researchers explore disease progression through transparent, interactive visualizations. :contentReference[oaicite:4]{index=4}

CompARE

Mon, 01 Jan 0001 00:00:00 +0000

Overview

CompARE is an interactive Shiny application that brings the methodology implemented in the CompAREdesign R package to an intuitive web interface. It enables researchers, clinicians and trialists to design clinical trials with composite endpoints without requiring programming experience.

The application provides a guided workflow for exploring different trial design scenarios, comparing assumptions and visualising their impact on sample size and statistical power.

Main Features

User-friendly web interface requiring no programming.
Design of clinical trials with composite endpoints.
Interactive comparison of alternative design scenarios.
Real-time calculation of sample size and power.
Dynamic visualisation of design assumptions and results.
Immediate export of numerical results and figures.

Applications

CompARE supports researchers during the planning stage of randomized clinical trials, helping them evaluate different design options before initiating a study. It is particularly useful for studies involving composite endpoints where conventional sample size methods may be insufficient.

Relationship with CompAREdesign

CompARE is built upon the statistical methodology implemented in the CompAREdesign R package. While the package provides a flexible programming environment for advanced users, CompARE offers an intuitive graphical interface that makes the methodology accessible to a much broader audience.

Availability

Web application:
R package:
Documentation:

Goal

The objective of CompARE is to make advanced statistical methodology for clinical trial design accessible, transparent and reproducible through an interactive web application that can be used by both statisticians and non-statistical researchers.