Cargando…
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6945587/ https://www.ncbi.nlm.nih.gov/pubmed/31910861 http://dx.doi.org/10.1186/s13063-019-3980-5 |
_version_ | 1783485209411321856 |
---|---|
author | 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 |
author_facet | 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 |
author_sort | Treweek, Shaun |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-6945587 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-69455872020-01-07 Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed 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 Trials Methodology 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. BioMed Central 2020-01-07 /pmc/articles/PMC6945587/ /pubmed/31910861 http://dx.doi.org/10.1186/s13063-019-3980-5 Text en © The Author(s). 2020 Open AccessThis 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. |
spellingShingle | Methodology 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 Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed |
title | Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed |
title_full | Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed |
title_fullStr | Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed |
title_full_unstemmed | Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed |
title_short | Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed |
title_sort | trial forge guidance 2: how to decide if a further study within a trial (swat) is needed |
topic | Methodology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6945587/ https://www.ncbi.nlm.nih.gov/pubmed/31910861 http://dx.doi.org/10.1186/s13063-019-3980-5 |
work_keys_str_mv | AT treweekshaun trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT bevansimon trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT bowerpeter trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT brielmatthias trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT campbellmarion trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT christiejacquie trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT collettclive trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT cottonseonaidh trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT devanedeclan trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT elfekyadel trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT galvinsandra trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT gardnerheidi trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT gillieskatie trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT hoodkerenza trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT jansenjan trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT littlefordroberta trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT parkeradwoa trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT ramsaycraig trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT restruplynne trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT sullivanfrank trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT torgersondavid trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT tremainliz trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT vonelmerik trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT westmorematthew trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT williamshywel trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT williamsonpaular trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded AT clarkemike trialforgeguidance2howtodecideifafurtherstudywithinatrialswatisneeded |