Evidence map›Paper›PMID 42254327›Full record

ArticleStatistics in biosciences2026

Design of Trials with Composite Endpoints with the R Package CompAREdesign.

Jordi Cortés-Martínez, Marta Bofill-Roig, Guadalupe Gómez-Melis

Abstract read
In one paragraph

Article in Statistics in biosciences, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Jordi Cortés-MartínezResearch 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.ORCID 0000-0002-3764-0795
Marta Bofill-RoigResearch 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.ORCID 0000-0002-4400-7541
Guadalupe Gómez-MelisResearch 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.ORCID 0000-0003-4252-4884

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Composite endpoints are frequently used as primary endpoints in clinical trials, especially those involving time-to-event data. Designing such trials poses significant challenges due to the frequent violation of the proportional hazards assumption when composite endpoints are used, even if the assumption holds true for individual components. Consequently, the conventional formulae for sample size calculation no longer apply. This paper introduces the R package CompAREdesign which incorporates novel methodologies developed by the authors to compute key trial design elements, including sample size and effect sizes, based on information of composite endpoint components. Additionally, the package offers features for designing trials with binary composite endpoints, and functions to simulate trials under a wide range of scenarios. While several R packages exist for analyzing trials with composite endpoints, CompAREdesign package is, to our knowledge, the first package specifically tailored to the design phase of such studies. CompAREdesign is available on CRAN.

Indexed as

Clinical trialComposite endpointsR packageSurvival analysis

Identifiers

PMID42254327
PMCPMC13233987

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.