s13063-022-06553-w.pdf (1.41 MB)
Trial Forge Guidance 3: randomised trials and how to recruit and retain individuals from ethnic minority groups-practical guidance to support better practice
journal contributionposted on 2022-09-28, 08:07 authored by Shoba Dawson, Katie Banister, Katie Biggs, Seonaidh Cotton, Declane Devane, Heidi Gardner, Katie Gillies, Gosala Gopalakrishnan, Talia Isaacs, Kamlesh Khunti, Alistair Nichol, Adwoa Parker, Amy M Russell, Victoria Shepherd, Frances Shiely, Gillian Shorter, Bella Starling, Hywel Williams, Andrew Willis, Miles D Witham, Shaun Treweek
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 under test should it prove effective. This does not always happen. The UK National Institute for Health and Care Research (NIHR) INCLUDE project identified many groups in the UK that are under-served by trials, including ethnic minorities. This guidance document presents four key recommendations for designing and running trials that include the ethnic groups needed by the trial. These are (1) ensure eligibility criteria and recruitment pathway do not limit participation in ways you do not intend, (2) ensure your trial materials are developed with inclusion in mind, (3) ensure staff are culturally competent and (4) 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. We encourage trial teams to follow the recommendations and, where possible, evaluate the strategies they use to implement them. Finally, while our primary audience is those designing, running and reporting trials, we hope funders, grant reviewers and approvals agencies may also find our guidance useful.
HRB Trials Methodology Research Network (HRB-TMRN) 2017 – 2021
Health Research BoardFind out more...
National Institute for Health Research (NIHR) Applied Research Collaboration East Midlands (ARC EM) and the NIHR Leicester Biomedical Research Centre (BRC)
Author affiliationDiabetes Research Centre, College of Life Sciences, University of Leicester
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