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

Shaun Treweek,Adwoa Parker,Simon Bevan,David Torgerson,Heidi Gardner,Erik Von Elm,Matthew Westmore,Lynne Restrup,Roberta Littleford,Paula Williamson ,Clive Collett,Peter Bower,Declan Devane,Liz Tremain,Craig R Ramsay ,Hywel C Williams ,Kerenza Hood,Adel Elfeky ,Frank Sullivan,Jacquie Christie,Marion K Campbell ,Katie Gillies,Jan O Jansen ,Seonaidh Cotton,Matthias Briel,Sandra Galvin,Mike Clarke

doi:10.1186/s13063-019-3980-5

Abstract

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.

Highlights

The evidence available to inform many routine process decisions in randomised trials is thin or weak
One of these is telephoning people who do not respond to postal invitations to take part in a trial, which is used in this example. (The other relates to optimising the patient information leaflet.) The Cochrane Review notes that the rating of high certainty is only for trials with low underlying recruitment of < 10% of
In other words, is there any reason to believe that the intervention would not work in your context given the contexts already studied? It is possible that evidence from Study Within A Trial (SWAT) will eventually splinter off to focus on certain contexts but, for we suggest pooling evaluations of the same intervention because there are so few SWAT evaluations of any intervention and this pooling will provide a basic foundation on which to build. e Where there may be no conceivable benefit or disadvantage for participants, they should be considered as balanced. f A benefit might be that the host trial recruits faster, or its data quality is improved

Summary

METHODOLOGY

Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed. Shaun Treweek1* , Simon Bevan, Peter Bower, Matthias Briel, Marion Campbell, Jacquie Christie, Clive Collett, Seonaidh Cotton, Declan Devane, Adel El Feky, Sandra Galvin, Heidi Gardner, Katie Gillies, Kerenza Hood, Jan Jansen, Roberta Littleford, Adwoa Parker, Craig Ramsay, Lynne Restrup, Frank Sullivan, David Torgerson, Liz Tremain, Erik von Elm, Matthew Westmore, Hywel Williams, Paula R.

Introduction

Background

Findings

Discussion