Abstract
Background
It is important to design clinical trials to include all those who may benefit from the intervention being tested. Several frameworks have been developed to help researchers think about the barriers to inclusion of particular under-served groups when designing a trial, but there is a lack of practical guidance on how to implement these frameworks. This paper describes the ACCESS project, the findings from each phase of the project and the guidance we developed (STEP UP) on how to design more inclusive trials.
Methods
Development of the STEP UP guidance had five phases: (1) Scoping literature review, (2) ‘roundtable’ discussion meetings, (3) redesign of trials, (4) interviews and (5) guidance document development, with input from public contributors and the ACCESS team.
Results
Over 40 experts contributed to the ACCESS project—patients and the public, clinicians, NHS research staff, trialists and other academics. The scoping review identified several strategies being used to improve inclusion, mostly around recruitment settings, but there was little evaluation of these strategies. The ‘roundtable’ discussions identified additional strategies being used across the UK and Ireland to improve inclusion, which were grouped into: Communication, Community engagement, Recruitment sites, Patient information, Flexibility, Recruitment settings, Consent process, Monitoring, Training for researchers and Incentives. These strategies were used to redesign three existing trials by applying one of the three INCLUDE frameworks (ethnicity, socioeconomic disadvantage, impaired capacity to consent) to one trial each, to produce the key recommendations for the guidance. Issues around implementation were explored in stakeholder interviews and key facilitators were identified: funders requesting information on inclusion, having the time and funding to implement strategies, dedicated staff, flexibility in trial protocols, and considering inclusion of under-served groups at the design stages. The STEP UP guidance is freely available at http://step-up-clinical-trials.co.uk.
Conclusion
Researchers should consider inclusivity to shape initial trial design decisions. Trial teams and funders need to ensure that trials are given both the resources and time needed to implement the STEP UP guidance and increase the opportunities to recruit a diverse population.
It is important to design clinical trials to include all those who may benefit from the intervention being tested. Several frameworks have been developed to help researchers think about the barriers to inclusion of particular under-served groups when designing a trial, but there is a lack of practical guidance on how to implement these frameworks. This paper describes the ACCESS project, the findings from each phase of the project and the guidance we developed (STEP UP) on how to design more inclusive trials.
Methods
Development of the STEP UP guidance had five phases: (1) Scoping literature review, (2) ‘roundtable’ discussion meetings, (3) redesign of trials, (4) interviews and (5) guidance document development, with input from public contributors and the ACCESS team.
Results
Over 40 experts contributed to the ACCESS project—patients and the public, clinicians, NHS research staff, trialists and other academics. The scoping review identified several strategies being used to improve inclusion, mostly around recruitment settings, but there was little evaluation of these strategies. The ‘roundtable’ discussions identified additional strategies being used across the UK and Ireland to improve inclusion, which were grouped into: Communication, Community engagement, Recruitment sites, Patient information, Flexibility, Recruitment settings, Consent process, Monitoring, Training for researchers and Incentives. These strategies were used to redesign three existing trials by applying one of the three INCLUDE frameworks (ethnicity, socioeconomic disadvantage, impaired capacity to consent) to one trial each, to produce the key recommendations for the guidance. Issues around implementation were explored in stakeholder interviews and key facilitators were identified: funders requesting information on inclusion, having the time and funding to implement strategies, dedicated staff, flexibility in trial protocols, and considering inclusion of under-served groups at the design stages. The STEP UP guidance is freely available at http://step-up-clinical-trials.co.uk.
Conclusion
Researchers should consider inclusivity to shape initial trial design decisions. Trial teams and funders need to ensure that trials are given both the resources and time needed to implement the STEP UP guidance and increase the opportunities to recruit a diverse population.
| Original language | English |
|---|---|
| Article number | 227 |
| Number of pages | 20 |
| Journal | BMC Medical Research Methodology |
| Volume | 24 |
| Early online date | 2 Oct 2024 |
| DOIs | |
| Publication status | Published - 2 Oct 2024 |
Bibliographical note
AcknowledgementsWe thank all the patients, public, NHS staff, trialists and other academics who have contributed to this project for their valuable input.
We thank the following PPI contributors, clinicians and researchers who wished to be acknowledged by name:
Public contributors: Tasleem Aziz, Shabir Aziz, Samina Begum, Trishna Bharadia, Ruby Bhatti OBE, Jatinder Bisla, Anna Ferguson Montague, Rashmi Kumar, Emily Lam, Dr Sarah Markham, Kirit Mistry, Manoj Mistry, Margaret Ogden, Yasmin Rahman, Al Richards, Deb Smith, Pam Smith, Kamil Sterniczuk.
Madeline Bell (Patient and Public Involvement and Engagement Lead), Liz Croot (Senior Lecturer), Emma Cutting (Clinical Trials Unit Neuroscience Theme Manager), Shoba Dawson (Senior Research Fellow), Shahida Din (Consultant Gastroenterologist), Christinana Dinah (Director, Research & Development), John Gibson (Research Ethics Committee Chair), Pip Hearty (Research Fellow), Kathryn Howlett (Research Nurse), Gemma Hughes (Trial Manager), Hanif Ismail (Patient and Public Involvement Manager), Ahmed Iqbal (Clinician Scientist), Katie Kirkham (Senior Trial Manager), Erik Lenguerrand (Senior Lecturer—Medical Statistician & Quantitative Epidemiologist), Fran Sherratt (Research Associate), Gordon Sloane (NIHR Clinical Lecturer), Georgina Turner (Clinical Research Team Leader), Louis Palmer (Clinical Studies Officer), Miles Parkes (Director NIHR Cambridge Biomedical Research Centre), Deepali Patel (Senior Clinical Trials Manager), Josephine M K Reynolds (Academic Clinical Fellow and GP Trainee), Constance Shiridzinomwa (Senior Project Manager, Academic Health Science Centre, AHSC), Hannah Stevenson (Clinical Trials Coordinator), Sally Stewart (Digital Infrastructure for Clinical Research Programme Manager), David White (Senior Research Fellow), Johanna White (Practice/Research Nurse), Octavia Wiseman (Research Fellow & Midwife).
Thank you to Professor David Torgerson and Professor Helen Hancock who were co-applicants on the ACCESS project.
Data Availability Statement
All data underlying the results, apart from the qualitative data from theinterviews, are available as part of the article and no additional source data are required. Qualitative data not included in this article cannot be made openly available due to the risk of identification of the participants. Requests for transcript data maybe made to the corresponding author and considered in
line with Data Protection.
Funding
This project was funded by the National Institute for Health and Care Research (NIHR) CTU Support Funding scheme. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
Keywords
- Inclusion
- Diversity
- Under-served groups
- Randomised controlled trials
- Research design