Doing trials within trials: a qualitative study of stakeholder views on barriers and facilitators to the routine adoption of methodology research in clinical trials

Abstract Background Randomised controlled trials are the cornerstone of evidence-based health care, yet many trials struggle with recruitment and retention. All too often the methodologies employed to address these problems are not evidence-based, as rigorous methodological research on these issues...

Full description

Bibliographic Details
Main Authors: Jo Rick, Mike Clarke, Alan A. Montgomery, Paul Brocklehurst, Rachel Evans, Peter Bower
Format: Article
Language:English
Published: BMC 2018-09-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-018-2862-6
_version_ 1818058618266714112
author Jo Rick
Mike Clarke
Alan A. Montgomery
Paul Brocklehurst
Rachel Evans
Peter Bower
author_facet Jo Rick
Mike Clarke
Alan A. Montgomery
Paul Brocklehurst
Rachel Evans
Peter Bower
author_sort Jo Rick
collection DOAJ
description Abstract Background Randomised controlled trials are the cornerstone of evidence-based health care, yet many trials struggle with recruitment and retention. All too often the methodologies employed to address these problems are not evidence-based, as rigorous methodological research on these issues is rare. The current research sought to identify barriers to the routine implementation of methodology research around recruitment and retention. Methods All registered UK clinical trials unit directors were sent a short questionnaire and invited to interview. Representatives of funding bodies and other stakeholders were also approached. Interviews were recorded and the content analysed. Results Data were grouped into four themes: acceptance of the need for methodological research; trial funding and development; trial processes; and organisational factors. The need to improve the evidence base for trials methodology is well established, but numerous barriers to implementation were perceived. Conclusions The knowledge and expertise required to routinely implement methodology research exists within the current research structures, and there are clear opportunities to develop the evidence base. However, for this to be achieved there is also a need for clear strategic coordination within the sector and promotion of the necessary resources.
first_indexed 2024-12-10T13:03:29Z
format Article
id doaj.art-77543f49998c4e2eb3c74b2e0d4bdcd1
institution Directory Open Access Journal
issn 1745-6215
language English
last_indexed 2024-12-10T13:03:29Z
publishDate 2018-09-01
publisher BMC
record_format Article
series Trials
spelling doaj.art-77543f49998c4e2eb3c74b2e0d4bdcd12022-12-22T01:47:55ZengBMCTrials1745-62152018-09-011911910.1186/s13063-018-2862-6Doing trials within trials: a qualitative study of stakeholder views on barriers and facilitators to the routine adoption of methodology research in clinical trialsJo Rick0Mike Clarke1Alan A. Montgomery2Paul Brocklehurst3Rachel Evans4Peter Bower5North West Hub for Trials Methodology, Manchester Academic Health Science Centre, University of ManchesterNorthern Ireland Methodology Hub, Centre for Public Health, Queens UniversityNottingham Clinical Trials Unit Faculty of Medicine and Health Sciences, Queens Medical Centre, University of NottinghamNWORTH Clinical Trials Unit, Bangor UniversityNWORTH Clinical Trials Unit, Bangor UniversityNorth West Hub for Trials Methodology, Manchester Academic Health Science Centre, University of ManchesterAbstract Background Randomised controlled trials are the cornerstone of evidence-based health care, yet many trials struggle with recruitment and retention. All too often the methodologies employed to address these problems are not evidence-based, as rigorous methodological research on these issues is rare. The current research sought to identify barriers to the routine implementation of methodology research around recruitment and retention. Methods All registered UK clinical trials unit directors were sent a short questionnaire and invited to interview. Representatives of funding bodies and other stakeholders were also approached. Interviews were recorded and the content analysed. Results Data were grouped into four themes: acceptance of the need for methodological research; trial funding and development; trial processes; and organisational factors. The need to improve the evidence base for trials methodology is well established, but numerous barriers to implementation were perceived. Conclusions The knowledge and expertise required to routinely implement methodology research exists within the current research structures, and there are clear opportunities to develop the evidence base. However, for this to be achieved there is also a need for clear strategic coordination within the sector and promotion of the necessary resources.http://link.springer.com/article/10.1186/s13063-018-2862-6RCTsSWATSMethodology research
spellingShingle Jo Rick
Mike Clarke
Alan A. Montgomery
Paul Brocklehurst
Rachel Evans
Peter Bower
Doing trials within trials: a qualitative study of stakeholder views on barriers and facilitators to the routine adoption of methodology research in clinical trials
Trials
RCTs
SWATS
Methodology research
title Doing trials within trials: a qualitative study of stakeholder views on barriers and facilitators to the routine adoption of methodology research in clinical trials
title_full Doing trials within trials: a qualitative study of stakeholder views on barriers and facilitators to the routine adoption of methodology research in clinical trials
title_fullStr Doing trials within trials: a qualitative study of stakeholder views on barriers and facilitators to the routine adoption of methodology research in clinical trials
title_full_unstemmed Doing trials within trials: a qualitative study of stakeholder views on barriers and facilitators to the routine adoption of methodology research in clinical trials
title_short Doing trials within trials: a qualitative study of stakeholder views on barriers and facilitators to the routine adoption of methodology research in clinical trials
title_sort doing trials within trials a qualitative study of stakeholder views on barriers and facilitators to the routine adoption of methodology research in clinical trials
topic RCTs
SWATS
Methodology research
url http://link.springer.com/article/10.1186/s13063-018-2862-6
work_keys_str_mv AT jorick doingtrialswithintrialsaqualitativestudyofstakeholderviewsonbarriersandfacilitatorstotheroutineadoptionofmethodologyresearchinclinicaltrials
AT mikeclarke doingtrialswithintrialsaqualitativestudyofstakeholderviewsonbarriersandfacilitatorstotheroutineadoptionofmethodologyresearchinclinicaltrials
AT alanamontgomery doingtrialswithintrialsaqualitativestudyofstakeholderviewsonbarriersandfacilitatorstotheroutineadoptionofmethodologyresearchinclinicaltrials
AT paulbrocklehurst doingtrialswithintrialsaqualitativestudyofstakeholderviewsonbarriersandfacilitatorstotheroutineadoptionofmethodologyresearchinclinicaltrials
AT rachelevans doingtrialswithintrialsaqualitativestudyofstakeholderviewsonbarriersandfacilitatorstotheroutineadoptionofmethodologyresearchinclinicaltrials
AT peterbower doingtrialswithintrialsaqualitativestudyofstakeholderviewsonbarriersandfacilitatorstotheroutineadoptionofmethodologyresearchinclinicaltrials