Evaluating a tool to improve engagement and recruitment of under-served groups in trials
Open accessAbstract
Background: Despite substantial awareness that certain groups (e.g. ethnic minorities) are under-represented and under-served in trials, limited progress has been made in addressing this. As well as a public service and ethical duty to recruit and engage under-served groups in relevant research, importantly, there are clear scientific benefits, for example, increased generalisability. The key aims of the current study were to explore the following: general barriers and facilitators to enhancing the recruitment of under-served groups into trials, the usability and value of a specific tool (INCLUDE Ethnicity Framework) to support engagement and recruitment of under-served groups, and ways of engaging diverse patient, public and community involvement and engagement (PCIE) groups. Methods: Firstly, researchers completed a brief survey in relation to a specific trial in which they were involved ( N = 182, 38% response rate). A second stage involved sampling survey respondents and asking them to complete the INCLUDE Ethnicity Framework and then a remote semi-structured interview ( N = 15). Qualitative data were analysed using thematic analysis. Finally, we conducted a consultation process with PCIE contributors primarily to develop guidelines for discussing the INCLUDE Ethnicity Framework with PCIE representatives. Results: Researchers recognised the importance of increasing engagement and recruitment of under-served groups within trials, but varied in their knowledge, ability and commitment to implementation in practice. The INCLUDE Ethnicity Framework was described by some as raising their awareness of how inclusion could be improved. Respondents highlighted a need for shared resources and wider structural change to facilitate such engagement. PCIE was identified, in the survey and interviews, as the most common method of trying to improve recruitment of under-served groups. However, researchers also commonly highlighted that PCIE groups were sometimes not very diverse. Conclusions: There is a need for researchers to consider the funding and time resources required for diverse and inclusive recruitment to trials and for funders to enable this. The INCLUDE Ethnicity Framework can help to raise awareness of inclusion challenges. This study indicates that it is important to take proactive steps to involve relevant under-served groups in PCIE and practical suggestions are made to facilitate this.
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There was a notion among some healthcare professionals that recruiting minority ethnic participants might be more cumbersome, demanding additional effort, time and resources.
“There was also a notion among some healthcare professionals that recruiting minority ethnic participants might be more cumbersome, demanding additional effort, time and resources [52, 59].”
From Enablers and barriers of clinical trial participation in adult patients from minority ethnic groups: a systematic review (2025) · cites this paper as [52]
The Structural barriers section reports that researchers expected measures to recruit under-served groups to lengthen study timelines and that recruiting at more diverse sites might be harder. The Role of PCIE/PPI section also reports difficulty securing enough time and funding. These findings support the perceived extra effort and resources, but they concern trial researchers and under-served groups broadly, not specifically healthcare professionals recruiting minority ethnic participants. (LLM, conf=0.84)
Experimental — accuracy not yet measuredFourteen included studies reported on why certain patients may have been overlooked for clinical trial participation.
“Fourteen studies reported on why certain patients may have been overlooked for clinical trial participation [12, 17, 38, 42, 44, 45, 52–55, 59, 63, 66, 69].”
From Enablers and barriers of clinical trial participation in adult patients from minority ethnic groups: a systematic review (2025) · cites this paper as [52]
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- Authors
- Morris, L., Dumville, J., Treweek, S., Miah, N., Curtis, F., & Bower, P.
- Affiliations
- Manchester Academic Health Science Centre (GB)
- University of Aberdeen (GB)
- National Institute for Health and Care Research (GB)
- Corresponding author
- Morris, Lydia
- Venue
- Trials
- Published
- 2022-10-09
- Volume
- 23
- Issue
- 1
- Pages
- 867-867
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC9549666
- OpenAlex
- W4303940403
- Cited by
- 32
- References
- 16
- Citations by year
- 2026: 5 · 2025: 10 · 2024: 12 · 2023: 5
- FWCI
- 5.95
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Trials (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (publishedVersion, other-oa)
- Aberdeen University Research Archive (Aberdeen University) (submittedVersion, cc-by)
- Aberdeen University Research Archive (Aberdeen University) (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- National Institute for Health Research Applied Research Collaboration Greater Manchester
- 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
- Social Sciences › Sociology and Political Science › Cultural Competency in Health Care
- Keywords
- underrepresented groups, ethnic minority recruitment, trial recruitment, patient and public involvement, community participation, diversity in clinical trials, barriers and facilitators, research inclusion, researcher attitudes
- MeSH terms
- Clinical Trials as Topic, Humans, Surveys and Questionnaires, Research Design, Research Personnel
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