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

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: Who should my trial apply to? Are the groups identified likely to respond in different ways? Will my study intervention make it harder for some groups to engage? 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.

Trial Forge Guidance 3: randomised trials and how to recruit and retain individuals from ethnic minority groups—practical guidance to support better practice

“…Some strategies may work well for one group but be completely ineffective for others. Ethnic minority groups are not homogeneous [ 6 ]. There are other things trial teams can consider including accounting for multiple and complementary strategies to improve inclusion (see for example Bodicoat et al [ 10 ]) but the four recommendations we propose are an important and realistic place to begin.…”

“… Always ask the trial team whether an eligibility criterion may disproportionally affect the ability of one or more ethnic minority groups to take part in the trial [ 6 ]. Avoid subjective eligibility criteria particularly those based on language.…”

“…There is plenty of evidence that ethnic minority groups are under-represented in trials [ 2 – 5 ]. INCLUDE, Trial Forge ( https://www.trialforge.org ) and others have recently developed the INCLUDE Ethnicity Framework ( https://www.trialforge.org/trial-forge-centre/include/ ), which helps trial teams to think about how disease, intervention and design influence the ability of people from different ethnic backgrounds to take part in a trial [ 6 ]. The aim is to make it more likely that trial results are widely applicable and acceptable to all those who could benefit.…”

‘Language has been granted too much power’.1,p.1 Challenging the power of words with time and flexibility in the precommencement stage of research involving those with cognitive impairment

“…8,22 The National Institute for Health and Care Research Include Framework is rightly raising the need to be more inclusive in recruiting trial participants, but the same needs to apply to prestudy design. 23 We recognize that for any researcher, but particularly for those who do not routinely work on topics relating to types of dementia or learning disabilities, the challenge to 'get it right' can feel daunting, and there is potential for hurt and harm to ensue, both for the people they seek (or fail) to involve and inexperienced and experienced researchers. We suggest that established and formalized communi-…”

Value and engagement: what can clinical trials learn from techniques used in not-for-profit marketing?

“…This concept underpins the National Institute for Health Research (NIHR) INCLUDE initiative, which aims to help trial teams think more carefully about who should be in their trial to make sure trials better serve groups who have been under-served by research in the past [ 5 ]. The INCLUDE Ethnicity Framework presents questions trial teams should ask themselves when considering the ethnic groups who must be included in the trial for the results to be applicable [ 6 ]. Knowing your audience, the people you wish to engage, is the first step in planning recruitment and retention, which is an essential activity.…”