Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process
Open accessPublished version of a preprint
Abstract
Background: Participants in clinical research studies often do not reflect the populations for which healthcare interventions are needed or will be used. Enhancing representation of under-served groups in clinical research is important to ensure that research findings are widely applicable. We describe a multicomponent workstream project to improve representation of under-served groups in clinical trials. Methods: The project comprised three main strands: (1) a targeted scoping review of literature to identify previous work characterising under-served groups and barriers to inclusion, (2) surveys of professional stakeholders and participant representative groups involved in research delivery to refine these initial findings and identify examples of innovation and good practice and (3) a series of workshops bringing together key stakeholders from funding, design, delivery and participant groups to reach consensus on definitions, barriers and a strategic roadmap for future work. The work was commissioned by the UK National Institute for Health Research Clinical Research Network. Output from these strands was integrated by a steering committee to generate a series of goals, workstream plans and a strategic roadmap for future development work in this area. Results: ‘Under-served groups’ was identified and agreed by the stakeholder group as the preferred term. Three-quarters of stakeholders felt that a clear definition of under-served groups did not currently exist; definition was challenging and context-specific, but exemplar groups (e.g. those with language barriers or mental illness) were identified as under-served. Barriers to successful inclusion of under-served groups could be clustered into communication between research teams and participant groups; how trials are designed and delivered, differing agendas of research teams and participant groups; and lack of trust in the research process. Four key goals for future work were identified: building long-term relationships with under-served groups, developing training resources to improve design and delivery of trials for under-served groups, developing infrastructure and systems to support this work and working with funders, regulators and other stakeholders to remove barriers to inclusion. Conclusions: The work of the INCLUDE group over the next 12 months will build on these findings by generating resources customised for different under-served groups to improve the representativeness of trial populations.
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The NIHR-funded INCLUDE initiative proposed a framework to increase the number of underserved trial participants from minority ethnic groups.
“A recent initiative funded by the NIHR, named “Innovations in Clinical Trial Design and Delivery for the Under-served” (INCLUDE), proposed a framework to increase the number of underserved trial participants from minority ethnic groups [24–26].”
From Enablers and barriers of clinical trial participation in adult patients from minority ethnic groups: a systematic review (2025) · cites this paper as [26]
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- Authors
- Witham, M. D., Anderson, E., Carroll, C., Dark, P. M., Down, K., Hall, A. S., Knee, J., Maier, R. H., Mountain, G. A., Nestor, G., Oliva, L., Prowse, S. R., Tortice, A., Wason, J., Rochester, L., & On behalf of the INCLUDE writing group
- Affiliations
- NIHR Newcastle Biomedical Research Centre (GB)
- Newcastle University (GB)
- University of Plymouth (GB)
- University of Manchester (GB)
- Leeds General Infirmary (GB)
- NIHR Research Delivery Network (GB)
- University of Bradford (GB)
- National Institute for Health and Care Research (GB)
- University of Aberdeen (GB)
- University of Cambridge (GB)
- Corresponding author
- Rochester, Lynn
- ORCID
- Venue
- Trials
- Published
- 2020-08-01
- Volume
- 21
- Issue
- 1
- Pages
- 694-694
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC7395975
- OpenAlex
- W3046271607
- Cited by
- 259
- References
- 20
- Citations by year
- 2026: 29 · 2025: 46 · 2024: 58 · 2023: 38 · 2022: 50 · 2021: 37 · 2020: 1
- FWCI
- 23.77
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Trials (publishedVersion, cc-by)
- Research Square (acceptedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (publishedVersion, cc-by)
- Aberdeen University Research Archive (Aberdeen University) (submittedVersion)
- PEARL (University of Plymouth) (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Research Explorer (The University of Manchester) (submittedVersion)
- Apollo (University of Cambridge) (submittedVersion, cc-by)
- Apollo (cc-by)
- Apollo
- Funders
- National Institute for Health Research (N/A)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Health Professions › General Health Professions › Mental Health and Patient Involvement
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- diversity in clinical trials, barriers to inclusion, stakeholder engagement, strategic roadmap, research trust, language barriers, mental illness
- MeSH terms
- Clinical Trials as Topic, Cross-Sectional Studies, United Kingdom, Humans, Medically Underserved Area, Patient Participation, Surveys and Questionnaires, Research Design, Consensus, Trust
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