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

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

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.

Citation

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 , P R 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

Publication

Trials

Status

Peer reviewed

DOI

https://doi.org/10.1186/s13063-018-2535-5

ISSN

1745-6215

Type

Journal article

Rights

© 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.

Description

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.

Collections

University of St Andrews Research

URI

http://hdl.handle.net/10023/12783

St Andrews Research Repository