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Trials
Published in: Trials 1/2020

Open Access 01-12-2020 | Methodology

Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed

Authors: Shaun Treweek, Simon Bevan, Peter Bower, Matthias Briel, Marion Campbell, Jacquie Christie, Clive Collett, Seonaidh Cotton, Declan Devane, Adel El Feky, Sandra Galvin, Heidi Gardner, Katie Gillies, Kerenza Hood, Jan Jansen, Roberta Littleford, Adwoa Parker, Craig Ramsay, Lynne Restrup, Frank Sullivan, David Torgerson, Liz Tremain, Erik von Elm, Matthew Westmore, Hywel Williams, Paula R. Williamson, Mike Clarke

Published in: Trials | Issue 1/2020

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Abstract

The evidence base available to trialists to support trial process decisions—e.g. how best to recruit and retain participants, how to collect data or how to share the results with participants—is thin. One way to fill gaps in evidence is to run Studies Within A Trial, or SWATs. These are self-contained research studies embedded within a host trial that aim to evaluate or explore alternative ways of delivering or organising a particular trial process.
SWATs are increasingly being supported by funders and considered by trialists, especially in the UK and Ireland. At some point, increasing SWAT evidence will lead funders and trialists to ask: given the current body of evidence for a SWAT, do we need a further evaluation in another host trial? A framework for answering such a question is needed to avoid SWATs themselves contributing to research waste.
This paper presents criteria on when enough evidence is available for SWATs that use randomised allocation to compare different interventions.
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Metadata
Title
Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed
Authors
Shaun Treweek
Simon Bevan
Peter Bower
Matthias Briel
Marion Campbell
Jacquie Christie
Clive Collett
Seonaidh Cotton
Declan Devane
Adel El Feky
Sandra Galvin
Heidi Gardner
Katie Gillies
Kerenza Hood
Jan Jansen
Roberta Littleford
Adwoa Parker
Craig Ramsay
Lynne Restrup
Frank Sullivan
David Torgerson
Liz Tremain
Erik von Elm
Matthew Westmore
Hywel Williams
Paula R. Williamson
Mike Clarke
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3980-5

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