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

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State: Public
Version: Final published version
License: CC BY 4.0
Serval ID
serval:BIB_84C245EBEC7D
Type
Article: article from journal or magazin.
Publication sub-type
Review (review): journal as complete as possible of one specific subject, written based on exhaustive analyses from published work.
Collection
Publications
Institution
Title
Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed.
Journal
Trials
Author(s)
Treweek S., Bevan S., Bower P., Briel M., Campbell M., Christie J., Collett C., Cotton S., Devane D., El Feky A., Galvin S., Gardner H., Gillies K., Hood K., Jansen J., Littleford R., Parker A., Ramsay C., Restrup L., Sullivan F., Torgerson D., Tremain L., von Elm E., Westmore M., Williams H., Williamson P.R., Clarke M.
ISSN
1745-6215 (Electronic)
ISSN-L
1745-6215
Publication state
Published
Issued date
07/01/2020
Peer-reviewed
Oui
Volume
21
Number
1
Pages
33
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
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.
Keywords
Clinical Decision-Making, Evidence-Based Medicine/standards, Humans, Practice Guidelines as Topic/standards, Randomized Controlled Trials as Topic/standards, Research Design/standards
Pubmed
Web of science
Open Access
Yes
Create date
10/01/2020 11:45
Last modification date
08/08/2024 6:36
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