Developing the INCLUDE Ethnicity Framework—a tool to help trialists design trials that better reflect the communities they serve

Treweek, Shaun; Banister, Katie; Bower, Peter; Cotton, Seonaidh; Devane, Declan; Gardner, Heidi R.; Isaacs, Talia; Nestor, Gary; Oshisanya, Adepeju; Parker, Adwoa; Rochester, Lynn; Soulsby, Irene; Williams, Hywel; Witham, Miles D.

Abstract

Background

Ensuring that a trial is designed so that its participants reflect those who might benefit from the results, or be spared harms, is key to the potential benefits of the trial reaching all they should. This paper describes the process, facilitated by Trial Forge, that was used between July 2019 and October 2020 to develop the INCLUDE Ethnicity Framework, part of the wider INCLUDE initiative from the National Institute for Health Research to improve inclusion of under-served groups in clinical research studies.

Methods

Development of the Framework was done in seven phases: (1) outline, (2) initial draft, (3) stakeholder meeting, (4) modify draft, (5) Stakeholder feedback, (6) applying the Framework and (7) packaging. Phases 2 and 3 were face-to-face meetings. Consultation with stakeholders was iterative, especially phases 4 to 6. Movement to the next phase was done once all or most stakeholders were comfortable with the results of the current phase. When there was a version of the Framework that could be considered final, the Framework was applied to six trials to create a set of examples (phase 6). Finally, the Framework, guidance and examples were packaged ready for dissemination (phase 7).

Results

A total of 40 people from stakeholder groups including patient and public partners, clinicians, funders, academics working with various ethnic groups, trial managers and methodologists contributed to the seven phases of development. The Framework comprises two parts. The first part is a list of four key questions:

1. Who should my trial apply to?

2. Are the groups identified likely to respond in different ways?

3. Will my study intervention make it harder for some groups to engage?

4. Will the way I have designed the study make it harder for some groups to engage?

The second part is a set of worksheets to help trial teams address these questions. The Framework can be used for any stage of trial, for a healthcare intervention in any disease area. The Framework was launched on 1st October 2020 and is available open access at the Trial Forge website: https://www.trialforge.org/trial-forge-centre/include/.

Conclusion

Thinking about the number of people in our trials is not enough: we need to start thinking more carefully about who our participants are.

Citation

Treweek, S., Banister, K., Bower, P., Cotton, S., Devane, D., Gardner, H. R., Isaacs, T., Nestor, G., Oshisanya, A., Parker, A., Rochester, L., Soulsby, I., Williams, H., & Witham, M. D. (2021). Developing the INCLUDE Ethnicity Framework—a tool to help trialists design trials that better reflect the communities they serve. Trials, 22(1), Article 337. https://doi.org/10.1186/s13063-021-05276-8

• Journal Article Type: Article
• Acceptance Date: Apr 16, 2021
• Online Publication Date: May 10, 2021
• Publication Date: 2021-12
• Deposit Date: May 13, 2021
• Publicly Available Date: May 13, 2021
• Journal: Trials
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 22
• Issue: 1
• Article Number: 337
• DOI: https://doi.org/10.1186/s13063-021-05276-8
• Keywords: Medicine (miscellaneous); Pharmacology (medical)
• Public URL: https://nottingham-repository.worktribe.com/output/5528707
• Publisher URL: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05276-8
• Additional Information: Received: 22 January 2021; Accepted: 16 April 2021; First Online: 10 May 2021; : ; : Ethical approval was not required for this work. Members of the public who took part did so as patient and public partners helping to drive and shape the work, not as research participants.; : Not applicable for this article.; : PB is Health Services Research Speciality Lead for the NIHR Clinical Research Network. ST is an Editor-in-Chief for Trials. HW was director of the NIHR Health Technology Assessment Programme 2015 to 2020. MDW is national speciality lead for the NIHR Ageing Clinical Research Network. GN, LR and MDW are part of the NIHR INCLUDE project steering group. All other authors declare that they have no competing interests.