The guidance, published in BMC Trials [17 August 2022], makes four recommendations for designing and running trials that include the ethnic groups needed by the trial. These are:
- Ensure eligibility criteria and recruitment pathway do not limit participation in ways you do not intend.
- Ensure your trial materials are developed with inclusion in mind.
- Ensure staff are culturally competent.
- Build trusting partnerships with community organisations that work with ethnic minority groups.
Each recommendation comes with best practice advice, public contributor testimonials, examples of the inclusion problem tackled by the recommendation, or strategies to mitigate the problem, as well as a collection of resources to support implementation of the recommendations.
Dr Shoba Dawson, Research Fellow at the Centre for Academic Primary Care, University of Bristol and lead author of the guidance, said: “Randomised trials, especially those intended to directly inform clinical practice and policy, should be designed to reflect all those who could benefit from the intervention being tested. As the NIHR INCLUDE project showed, this does not always happen. We would like to encourage trial teams to follow the recommendations and, where possible, evaluate the strategies they use to implement them.”
Professor Shaun Treweek, from the Health Services Research Unit, University of Aberdeen and co-author of the guidance, said : “Trials teams need to think carefully about who needs to be in their trial for it to benefit all those it should. This is not just, or even mainly, about biology: a treatment offered in a place people do not visit, at a time when they cannot engage, in a language they do not understand by a person their community is unable to trust will not benefit these individuals, even if it works well for others in society. Inequalities will persist without change."
The guidance was produced for Trial Forge in collaboration with researchers from the University of Aberdeen, University of Sheffield, National University of Ireland Galway, Imperial College London, University College London, University of Leicester, University College Dublin, University of York, University of Leeds, Cardiff University, University College Cork, Queen’s University Belfast, NIHR Manchester Biomedical Research Centre, Nottingham University Hospitals NHS Trust, and NIHR Newcastle Biomedical Research Centre.
Paper: Trial Forge Guidance 3: Randomised trials and how to recruit and retain individuals from ethnic minority groups– practical guidance to support better practice. Shoba Dawson et al. Published in BMC Trials. August 2022.