Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Research

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

Authors: Jo Rick, Mike Clarke, Alan A. Montgomery, Paul Brocklehurst, Rachel Evans, Peter Bower

Published in: Trials | Issue 1/2018

Login to get access

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.
Literature
1.
Clarke M, Savage G, Maguire L, McAneney H. The SWAT (study within a trial) programme; embedding trials to improve the methodological design and conduct of future research. Trials. 2015;16:P209.CrossRefPubMedCentral
2.
Macleod M, Michie S, Roberts I, Dirnagl U, Chalmers I, Ioannidis J, Al Shahi Salman R, Chan A, Glasziou P. Biomedical research: increasing value, reducing waste. Lancet. 2014;383:101–4.CrossRefPubMed
3.
Cockayne S, Fairhurst C, Adamson J, Hewitt C, Hull R, Hicks K, Keenan A-M, Lamb SE, Green L, McIntosh C, et al. An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial. Trials. 2017;18:144.CrossRefPubMedPubMedCentral
4.
Treweek S, Lockhart P, PitKethly M, Cook J, Kjeldstrøm M, Johansen M, Taskila T, Sullivan F, Wilson S, Jackson C, et al. Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. BMJ Open. 2013;3:e002360.CrossRefPubMedPubMedCentral
5.
Brueton V, Tierney J, Stenning S, Harding S, Meredith S, Nazareth I, Rait G. Strategies to improve retention in randomised trials. Cochrane Database Syst Rev 2013, Issue 12. Art. No.: MR000032. doi: https://​doi.​org/​10.​1002/​14651858.MR000032.pub2.
6.
Graffy J, Bower P, Ward E, Wallace P, Delaney B, Kinmonth A, Collier D, Miller J. Trials within trials? Researcher, funder and ethical perspectives on the practicality and acceptability of nesting trials of recruitment methods in existing primary care trials. BMC Med Res Methodol. 2010;10:38.CrossRefPubMedPubMedCentral
7.
Rick J, Graffy J, Knapp P, Small N, Collier D, Eldridge S, Kennedy A, Salisbury C, Treweek S, Torgerson D, et al. Systematic Techniques for Assisting Recruitment to Trials (START): study protocol and preliminary findings on a platform for nesting studies of recruitment interventions across multiple trials. Trials. 2014;15:407.CrossRefPubMedPubMedCentral
8.
Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19:349–57.CrossRefPubMed
9.
Iles V, Sutherland K. Organisational change: a review for health care managers, professionals and researchers. London: School of Hygiene & Tropical Medicine; 2001.
10.
Treweek S, Altman D, Bower P, Campbell M, Chalmers I, Cotton S, Craig P, Crosby D, Davidson P, Devane D, et al. Making randomised trials more efficient: report of the first meeting to discuss the Trial Forge platform. Trials. 2015;16:261.CrossRefPubMedPubMedCentral
11.
Skea ZC, Treweek S, Gillies K. It's trying to manage the work’: a qualitative evaluation of recruitment processes within a UK multicentre trial. BMJ Open. 2017;7(8):e016475.CrossRefPubMedPubMedCentral
12.
Campbell M, Snowdon C, Francis C, Elbourne D, McDonald A, Knight R, Entwistle V, Garcia J, Roberts I, Grant A. Recruitment to randomised trials: strategies for trial enrolment and participation study: the STEPS study. Health Technol Assess. 2007;11(48)
13.
Rosala-Hallas A, Bhangu A, Blazeby J, Bowman L, Clarke M, Lang T, Nasser M, Siegfried N, Soares-Weiser K, Sydes MR, et al. Global health trials methodological research agenda: results from a priority setting exercise. Trials. 2018;19:48.CrossRefPubMedPubMedCentral
14.
Metadata
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
Authors
Jo Rick
Mike Clarke
Alan A. Montgomery
Paul Brocklehurst
Rachel Evans
Peter Bower
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2862-6

Other articles of this Issue 1/2018

Trials 1/2018 Go to the issue

Study protocol

The efficacy and safety of herbal medicine BHH10 in postmenopausal women with osteoporosis: study protocol for a phase II, multicenter, randomized, double-blinded, placebo-controlled clinical trial

Research

Fair inclusion of pregnant women in clinical trials: an integrated scientific and ethical approach

Study protocol

Core Outcome Set for GROwth restriction: deVeloping Endpoints (COSGROVE)

Update

Statistical analysis plan for a cluster-randomized crossover trial comparing the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units (the ICU Visits Study)

Study protocol

A multicentre, randomized, controlled open-label trial to compare an Accelerated Rule-Out protocol using combined prehospital copeptin and in-hospital high sensitive troponin with standard rule-out in patients suspected of acute Myocardial Infarction – the AROMI trial

Study protocol

Improving eye care in residential aged care facilities using the Residential Ocular Care (ROC) model: study protocol for a multicentered, prospective, customized, and cluster randomized controlled trial in Australia