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

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-contain...

Full description

Saved in:
Bibliographic Details
Published in:Current controlled trials in cardiovascular medicine 2020-01, Vol.21 (1), p.33-33, Article 33
Main Authors: Treweek, Shaun, Bevan, Simon, Bower, Peter, Briel, Matthias, Campbell, Marion, Christie, Jacquie, Collett, Clive, Cotton, Seonaidh, Devane, Declan, El Feky, Adel, Galvin, Sandra, Gardner, Heidi, Gillies, Katie, Hood, Kerenza, Jansen, Jan, Littleford, Roberta, Parker, Adwoa, Ramsay, Craig, Restrup, Lynne, Sullivan, Frank, Torgerson, David, Tremain, Liz, von Elm, Erik, Westmore, Matthew, Williams, Hywel, Williamson, Paula R, Clarke, Mike
Format: Article
Language:English
Subjects:
Clinical Decision-Making
Clinical trials
Decision making
Evidence-Based Medicine - standards
Funding
Humans
Intervention
Medical research
Methodology
Methods
Practice Guidelines as Topic - standards
Randomized Controlled Trials as Topic - standards
Research & development expenditures
Research Design - standards
Retention
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:1745-6215
1745-6215
DOI:10.1186/s13063-019-3980-5