Evidence map›Paper›PMID 42292740›Full record

ReviewDialogues in health2026

A visual framework for classifying adaptive design clinical trials using the GATE frame and PICO terminology.

David Lora, Antonio Lalueza Blanco, Guillermo Maestro de la Calle, Ana García Reyne, María Ruíz-Ruigómez, Enrique J Calderón, Miguel Menéndez-Orenga

Abstract readReview
In one paragraph

Review in Dialogues in health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

7 authors.

David LoraInstituto de Investigación Sanitaria del Hospital Universitario 12 de Octubre (imas12), Madrid, Spain.
Antonio Lalueza BlancoInstituto de Investigación Sanitaria del Hospital Universitario 12 de Octubre (imas12), Madrid, Spain.
Guillermo Maestro de la CalleFacultad de Medicina, Universidad Complutense de Madrid (UCM), Madrid, Spain.
Ana García ReyneInstituto de Investigación Sanitaria del Hospital Universitario 12 de Octubre (imas12), Madrid, Spain.
María Ruíz-RuigómezInstituto de Investigación Sanitaria del Hospital Universitario 12 de Octubre (imas12), Madrid, Spain.
Enrique J CalderónInstituto de Biomedicina de Sevilla, Hospital Universitario Virgen del Rocío, Consejo Superior de Investigaciones Científicas, Universidad de Sevilla, Sevilla, Spain.
Miguel Menéndez-OrengaInstituto de Investigación Sanitaria del Hospital Universitario 12 de Octubre (imas12), Madrid, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

An adaptive design of a clinical trial is a trial design that offers pre-planned opportunities to use accumulating trial data to modify aspects of an ongoing trial while preserving the validity and integrity of that trial. The Consolidated Standards Of Reporting Trials (CONSORT) 2025 statements show the minimum information that should be included in the reporting of trials to ensure that trial protocols and trials reports are clear and transparent. Pre-planned interim analysis of adaptive clinical trials can modify the study population, the randomization, the intervention arms, the primary outcome or the clinical trial phase. Such key aspects can be reported using the Adaptive designs CONSORT Extension (ACE) statement, and additionally, conceptualised and represented using the Graphic Appraisal Tool for Epidemiological (GATE) and the PICO terminology (Population, Intervention, Comparison and Outcome). The main purpose of this article is to show how the GATE frame can complement the ACE guidelines by serving as a teaching tool to explain adaptive design clinical trials to a clinical or nonspecialist audience using examples of clinical trials for the prevention and treatment of COVID-19.

Indexed as

Adaptive designClinical trialCONSORT adaptiveCOVID-19PICO terminologyPublic health preparednessTeaching tool

Identifiers

PMID42292740
PMCPMC13253079

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.