Evidence map›Paper›PMID 41271425›Full record

ArticleBMJ open2025

Trial characteristics, methods and reported challenges of decentralised clinical trials: a scoping review.

Alexandra Cussen, Katherine Littler

Abstract readScoping Review
In one paragraph

Article in BMJ open, 2025. 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. Review
  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

2 authors.

Alexandra CussenAdolescent Medicine, The Royal Children's Hospital Melbourne, Parkville, Victoria, Australia Alexandra.Cussen@rch.org.au.ORCID http://orcid.org/0000-0002-7737-4890
Katherine LittlerResearch for Health, World Health Organization, Geneva, Switzerland.

Funding

World Health Organization 001
6 · The paper itself

Abstract

objectivesTo map the landscape of decentralised clinical trials (DCTs) by summarising characteristics, methods and reported challenges of published DCTs.

designScoping review, reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews (PRISMA-ScR) checklist. DATA SOURCES: Ovid MEDLINE and PubMed were searched through to 21 August 2024. ELIGIBILITY CRITERIA: We included reports of completed DCTs (defined as a trial of an intervention, with a comparison arm, in which some or all trial activities occurred away from the trial centre). All intervention types were included. DATA EXTRACTION AND SYNTHESIS: A single reviewer extracted data to a structured extraction sheet. Descriptive statistics (frequencies) are reported for study characteristics and the terminology used to describe trial methods. Decentralised methods used were coded separately for each trial stage.

results53 papers met inclusion criteria. Most studies (34/53) were conducted in the USA. Mental health (18 studies) and COVID-19 (11 studies) were the predominant research areas. 24 (of 53) studies investigated pharmaceutical interventions, while others examined nutritional interventions, medical devices and behavioural interventions. Recruitment, screening and consent were commonly conducted remotely. A range of methods, including online, in-person and telemedicine, was used to collect outcome measures. Several studies experienced challenges related to participant retention and biased recruitment. Terminology regarding decentralisation was inconsistent across studies.

conclusionsDCTs are rapidly increasing in use, and commonly cited advantages include reduced costs and reduced participant burden. This review identifies key research areas using DCTs and highlights a need for standardised terminology, comprehensive reporting of methods and limitations, and robust regulatory frameworks. Development of formal ethical and reporting standards is essential to ensure effective and responsible implementation of DCTs in clinical research.

Indexed as

Clinical Trials as TopicPoliticsResearch DesignCOVID-19HumansSARS-CoV-2Clinical TrialDigital TechnologyResearch DesignReviewSTATISTICS & RESEARCH METHODS

Identifiers

PMID41271425
PMCPMC12658491

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.