Evidence map›Paper›PMID 40287818›Full record

ReviewUnited European gastroenterology journal2025

How to Survive and Succeed in the Design and Execution of a Collaborative Randomized Controlled Trial.

Enrique de-Madaria

Abstract readReview
In one paragraph

Review in United European gastroenterology journal, 2025. 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

1 author.

Enrique de-MadariaGastroenterology Department, Dr. Balmis General University Hospital-ISABIAL, Alicante, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This article guides the design and execution of successful collaborative randomized controlled trials (RCTs). Aimed at researchers looking to impact clinical practice, it highlights the advantages of RCTs over observational studies in driving clinical advancements. The article details essential steps in trial development, starting with assembling a core team of a principal investigator, experienced collaborator, methodologist, patient representative, and coordinator. Critical strategies for defining impactful research questions, selecting adequate primary endpoints, and developing a robust protocol are discussed. Additional emphasis is placed on patient-centered outcomes and data integrity, supported by carefully designed electronic case report forms. The article also covers strategies for recruiting collaborators, and managing ethical approvals across multiple centers. Ultimately, it offers insights from the author's experience, encouraging new researchers to overcome challenges in launching their first RCT and reinforcing the role of high-quality, multicentric research in enhancing patient care and clinical outcomes.

Indexed as

Multicenter Studies as TopicRandomized Controlled Trials as TopicResearch DesignCooperative BehaviorHumanscollaborative clinical trialsmulticenter studiespatient‐centered outcomesrandomized controlled trialsresearch methodology

Identifiers

PMID40287818
PMCPMC12269722

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.