Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed.
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Treweek S
Health Services Research Unit, University of Aberdeen, Aberdeen, UK. streweek@mac.com.
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Bevan S
National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, Southampton, UK.
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Bower P
MRC North West Hub for Trials Methodology Research, Centre for Primary Care and Health Services Research, University of Manchester, Manchester, UK.
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Briel M
Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.
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Campbell M
Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
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Christie J
GSK Medicines Research Centre, Stevenage, UK.
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Collett C
Health Research Authority, London, UK.
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Cotton S
Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
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Devane D
HRB-Trials Methodology Research Network, National University of Ireland Galway, Galway, Ireland.
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El Feky A
Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
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Galvin S
HRB-Trials Methodology Research Network, National University of Ireland Galway, Galway, Ireland.
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Gardner H
Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
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Gillies K
Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
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Hood K
Centre for Trials Research, College of Biomedical & Life Sciences, Cardiff University, Cardiff, UK.
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Jansen J
Division of Acute Care Surgery, University of Alabama at Birmingham, Birmingham, USA.
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Littleford R
University of Queensland Centre for Clinical Research, University of Queensland, Brisbane, Australia.
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Parker A
York Trials Unit, University of York, York, UK.
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Ramsay C
Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
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Restrup L
Public and patient representative, Aberdeen, UK.
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Sullivan F
School of Medicine, St Andrews University, St Andrews, UK.
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Torgerson D
York Trials Unit, University of York, York, UK.
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Tremain L
National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, Southampton, UK.
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von Elm E
Cochrane Switzerland, Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Lausanne, Switzerland.
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Westmore M
National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, Southampton, UK.
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Williams H
Centre of Evidence-Based Dermatology, Queen's Medical Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK.
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Williamson PR
MRC North West Hub for Trials Methodology Research, Department of Biostatistics University of Liverpool, Liverpool, UK.
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Clarke M
Northern Ireland Methodology Hub, Queen's University Belfast, Belfast, UK.
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English
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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Open access status
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gold
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Persistent URL
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https://folia.unifr.ch/global/documents/180008
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