Evidence map›Paper›PMID 40753414›Full record

GuidelineTrials2025

Trial Forge Guidance 5: ethical considerations in randomised Studies Within A Trial (SWATs).

Hanne Bruhn, Shaun Treweek, Charles Weijer, Matthias Briel, Mike Clarke, Rachel Crowley, Katie Gillies, Heidi Green, Ellen Murphy, Adwoa Parker and 3 more

Abstract readConsensus StatementGuideline
PubMed Full text at PMC Publisher
In one paragraph

Guideline in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Trial
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

13 authors.

Hanne BruhnTrials Research and Methodologies Unit, HRB Clinical Research Facility, University College Cork, Cork, Ireland.
Shaun TreweekAberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK.
Charles WeijerDepartments of Medicine and Philosophy, Western University, London, Canada.
Matthias BrielCLEAR Methods Center, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Mike ClarkeNorthern Ireland Methodology Hub, Centre for Public Health, Queen's University Belfast, Belfast, Northern Ireland.
Rachel CrowleyRare Disease Clinical Trial Network, University College Dublin & St Vincent's University Hospital, Dublin, Ireland.
Katie GilliesAberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK.
Heidi GreenFreelance Health Equity and Patient Involvement Specialist, London, UK.
Ellen MurphyTrials Research and Methodologies Unit, HRB Clinical Research Facility, University College Cork, Cork, Ireland.
Adwoa ParkerYork Trials Unit, Department of Health Sciences, University of York, York, UK.
Geneviève Shiely HayesTrials Research and Methodologies Unit, HRB Clinical Research Facility, University College Cork, Cork, Ireland.
Peter HartSchool of Public Health, University College Cork, Cork, Ireland.
Frances ShielyTrials Research and Methodologies Unit, HRB Clinical Research Facility, University College Cork, Cork, Ireland. f.shiely@ucc.ie.ORCID http://orcid.org/0000-0003-0969-8321

Funding

Health Research Board HRB-TMRN 2021-1
6 · The paper itself

Abstract

backgroundRandomised trials often struggle with recruitment, retention, and delays, impacting both finances and patient care. To improve trial processes, trialists can do Studies Within A Trial (SWATs) that compare trial process alternatives. A SWAT is a self-contained research study that is embedded within a host trial, or several host trials, with the aim of evaluating or exploring alternative ways of delivering or organising a particular trial process. Although SWATs are recognised by funders, there are differences in how they are implemented, such as different consent requirements in the UK and Ireland. This complicates SWAT conduct, raises ethical considerations, and highlights the need for standardised, ethical approaches to SWATs. The purpose of the current study was to devise guidance to address this.

methodsWe used existing systematic reviews, searched PubMed and the SWAT register, and contacted SWAT teams known to the authors to identify relevant randomised SWATs to include in our literature review. We extracted information on SWAT descriptives and 19 outcomes of interest pre-identified by the authors as being potential ethical considerations. We themed our findings. We held three consensus building fora, all including representatives from eight key stakeholder groups representing a broad range of roles in trials. We presented participants with two SWATs to start conversation on perceived ethical issues. We also incorporated the findings of our literature review. Consensus building fora were recorded, transcribed, and analysed using NVivo, focusing on ethical principles, challenges, and solutions.

resultsWe developed guidance on ethical considerations applicable to randomised SWATs. There are 14 ethical considerations covering all stages of a SWAT, from development and SWAT team selection to communication of results. The considerations are posed as questions, so trial teams can easily answer these when designing their SWAT.

conclusionsStudies Within A Trial are generally perceived to be low risk and low burden to participants. However, there are still varying ethical standards applied to these studies by researchers, sponsors, and ethics committees. These guidelines will be helpful to anyone planning or reviewing SWATs in understanding these differences and their ethical implications, and provide a practical guide for the ethical conduct of SWATs.

Indexed as

Ethics, ResearchRandomized Controlled Trials as TopicResearch DesignHumansSystematic Reviews as TopicMethodology guidanceResearch ethicsStudy within a trialSWATTrial ForgeTrial methodology

Identifiers

PMID40753414
PMCPMC12318429

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.