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 Claire Cotton; Declan Devane; Adel El Feky; Ella  Flemyng; Sandra Galvin; Heidi Rebecca Gardner; Kate 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^* (Corresponding Author), Simon Bevan, Peter Bower, Marion Campbell, Jacquie Christie, Mike Clarke, Clive Collett, Seonaidh Claire Cotton, Declan Devane, Adel El Feky, Ella Flemyng, Sandra Galvin, Heidi Rebecca Gardner, Kate Gillies, Jan Jansen, Roberta Littleford, Adwoa Parker, Craig Ramsay, Lynne Restrup, Frank SullivanDavid Torgerson, Liz Tremain, Matthew Westmore, Paula R. Williamson

^*Corresponding author for this work

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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
Journal	Trials
Volume	19
DOIs	https://doi.org/10.1186/s13063-018-2535-5
Publication status	Published - 23 Feb 2018

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10.1186/s13063-018-2535-5Licence: CC BY

Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)?
© 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
Final published version, 458 KBLicence: CC BY

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Treweek, S., Bevan, S., Bower, P., Campbell, M., Christie, J., Clarke, M., Collett, C., Cotton, S. C., Devane, D., El Feky, A., Flemyng, E., Galvin, S., Gardner, H. R., 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

Treweek, S, Bevan, S, Bower, P, Campbell, M, Christie, J, Clarke, M, Collett, C, Cotton, SC, Devane, D, El Feky, A, Flemyng, E, Galvin, S, Gardner, HR, 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

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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 {\textquoteleft}top tips{\textquoteright} 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.",

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AU - Christie, Jacquie

AU - Clarke, Mike

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AU - Devane, Declan

AU - El Feky, Adel

AU - Flemyng, Ella

AU - Galvin, Sandra

AU - Gardner, Heidi Rebecca

AU - Gillies, Kate

AU - Jansen, Jan

AU - Littleford, Roberta

AU - Parker, Adwoa

AU - Ramsay, Craig

AU - Restrup, Lynne

AU - Sullivan, Frank

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AU - Westmore, Matthew

AU - Williamson, Paula R.

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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.

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VL - 19

JO - Trials

JF - Trials

M1 - 139

ER -

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

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