Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)?

Shaun Treweek; Simon Bevan; Peter Bower; Marion Campbell; Jacquie Christie; Mike Clarke; Clive Collett; Seonaidh Cotton; Declan Devane; Adel El Feky; Ella Flemyng; Sandra Galvin; Heidi Gardner; Katie Gillies; Jan Jansen; Roberta Littleford; Adwoa Parker; Craig Ramsay; Lynne Restrup; Frank Sullivan; David Torgerson; Liz Tremain; Matthew Westmore; Paula R Williamson

doi:10.1186/s13063-018-2535-5

Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)?

Shaun Treweek
, Simon Bevan
, Peter Bower
, Marion Campbell
, Jacquie Christie
, Mike Clarke
, Clive Collett
, Seonaidh Cotton
, Declan Devane
, Adel El Feky
, Ella Flemyng
, Sandra Galvin
, Heidi Gardner
, Katie Gillies
, Jan Jansen
, Roberta Littleford
, Adwoa Parker
, Craig Ramsay
, Lynne Restrup
, Frank Sullivan

David Torgerson, Liz Tremain, Matthew Westmore, Paula R Williamson

Research output: Contribution to journal › Article › peer-review

Abstract

Randomised trials are a central component of all evidence-informed health care systems and the evidence coming from them helps to support health care users, health professionals and others to make more informed decisions about treatment. The evidence available to trialists to support decisions on design, conduct and reporting of randomised trials is, however, sparse. Trial Forge is an initiative that aims to increase the evidence base for trial decision-making and in doing so, to improve trial efficiency.

One way to fill gaps in evidence is to run Studies Within A Trial, or SWATs. This guidance document provides a brief definition of SWATs, an explanation of why they are important and some practical 'top tips' that come from existing experience of doing SWATs. We hope the guidance will be useful to trialists, methodologists, funders, approvals agencies and others in making clear what a SWAT is, as well as what is involved in doing one.

Original language	English
Article number	139
Number of pages	5
Journal	Trials
Volume	19
DOIs	https://doi.org/10.1186/s13063-018-2535-5
Publication status	Published - 23 Feb 2018

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© The Author(s). 2018. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
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Treweek, S., Bevan, S., Bower, P., Campbell, M., Christie, J., Clarke, M., Collett, C., Cotton, S., Devane, D., El Feky, A., Flemyng, E., Galvin, S., Gardner, H., Gillies, K., Jansen, J., Littleford, R., Parker, A., Ramsay, C., Restrup, L., ... Williamson, P. R. (2018). Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)? Trials, 19, Article 139. https://doi.org/10.1186/s13063-018-2535-5

@article{cad9b7b05cb142918eae1b1fb3b3c3b3,

title = "Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)?",

abstract = "Randomised trials are a central component of all evidence-informed health care systems and the evidence coming from them helps to support health care users, health professionals and others to make more informed decisions about treatment. The evidence available to trialists to support decisions on design, conduct and reporting of randomised trials is, however, sparse. Trial Forge is an initiative that aims to increase the evidence base for trial decision-making and in doing so, to improve trial efficiency.One way to fill gaps in evidence is to run Studies Within A Trial, or SWATs. This guidance document provides a brief definition of SWATs, an explanation of why they are important and some practical 'top tips' that come from existing experience of doing SWATs. We hope the guidance will be useful to trialists, methodologists, funders, approvals agencies and others in making clear what a SWAT is, as well as what is involved in doing one.",

author = "Shaun Treweek and Simon Bevan and Peter Bower and Marion Campbell and Jacquie Christie and Mike Clarke and Clive Collett and Seonaidh Cotton and Declan Devane and \{El Feky\}, Adel and Ella Flemyng and Sandra Galvin and Heidi Gardner and Katie Gillies and Jan Jansen and Roberta Littleford and Adwoa Parker and Craig Ramsay and Lynne Restrup and Frank Sullivan and David Torgerson and Liz Tremain and Matthew Westmore and Williamson, \{Paula R\}",

note = "The work described here was funded in part by the UK Network of MRC Hubs for Trials Methodology Research and the Irish Trials Methodology Research Network.",

year = "2018",

month = feb,

day = "23",

doi = "10.1186/s13063-018-2535-5",

language = "English",

volume = "19",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central",

}

Treweek, S, Bevan, S, Bower, P, Campbell, M, Christie, J, Clarke, M, Collett, C, Cotton, S, Devane, D, El Feky, A, Flemyng, E, Galvin, S, Gardner, H, Gillies, K, Jansen, J, Littleford, R, Parker, A, Ramsay, C, Restrup, L, Sullivan, F, Torgerson, D, Tremain, L, Westmore, M & Williamson, PR 2018, 'Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)?', Trials, vol. 19, 139. https://doi.org/10.1186/s13063-018-2535-5

TY - JOUR

T1 - Trial Forge Guidance 1

T2 - what is a Study Within A Trial (SWAT)?

AU - Treweek, Shaun

AU - Bevan, Simon

AU - Bower, Peter

AU - Campbell, Marion

AU - Christie, Jacquie

AU - Clarke, Mike

AU - Collett, Clive

AU - Cotton, Seonaidh

AU - Devane, Declan

AU - El Feky, Adel

AU - Flemyng, Ella

AU - Galvin, Sandra

AU - Gardner, Heidi

AU - Gillies, Katie

AU - Jansen, Jan

AU - Littleford, Roberta

AU - Parker, Adwoa

AU - Ramsay, Craig

AU - Restrup, Lynne

AU - Sullivan, Frank

AU - Torgerson, David

AU - Tremain, Liz

AU - Westmore, Matthew

AU - Williamson, Paula R

N1 - The work described here was funded in part by the UK Network of MRC Hubs for Trials Methodology Research and the Irish Trials Methodology Research Network.

PY - 2018/2/23

Y1 - 2018/2/23

N2 - Randomised trials are a central component of all evidence-informed health care systems and the evidence coming from them helps to support health care users, health professionals and others to make more informed decisions about treatment. The evidence available to trialists to support decisions on design, conduct and reporting of randomised trials is, however, sparse. Trial Forge is an initiative that aims to increase the evidence base for trial decision-making and in doing so, to improve trial efficiency.One way to fill gaps in evidence is to run Studies Within A Trial, or SWATs. This guidance document provides a brief definition of SWATs, an explanation of why they are important and some practical 'top tips' that come from existing experience of doing SWATs. We hope the guidance will be useful to trialists, methodologists, funders, approvals agencies and others in making clear what a SWAT is, as well as what is involved in doing one.

AB - Randomised trials are a central component of all evidence-informed health care systems and the evidence coming from them helps to support health care users, health professionals and others to make more informed decisions about treatment. The evidence available to trialists to support decisions on design, conduct and reporting of randomised trials is, however, sparse. Trial Forge is an initiative that aims to increase the evidence base for trial decision-making and in doing so, to improve trial efficiency.One way to fill gaps in evidence is to run Studies Within A Trial, or SWATs. This guidance document provides a brief definition of SWATs, an explanation of why they are important and some practical 'top tips' that come from existing experience of doing SWATs. We hope the guidance will be useful to trialists, methodologists, funders, approvals agencies and others in making clear what a SWAT is, as well as what is involved in doing one.

U2 - 10.1186/s13063-018-2535-5

DO - 10.1186/s13063-018-2535-5

M3 - Article

C2 - 29475444

SN - 1745-6215

VL - 19

JO - Trials

JF - Trials

M1 - 139

ER -

Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)?

Abstract

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