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

Dawson, Shoba, Banister, Katie, Biggs, Katie, Cotton, Seonaidh, Devane, Declane, Gardner, Heidi, Gillies, Katie, Gopalakrishnan, Gosala, Isaacs, Talia, Khunti, Kamlesh, Nichol, Alistair, Parker, Adwoa, Russell, Amy M., Shepherd, Victoria ORCID: https://orcid.org/0000-0002-7687-0817, Shiely, Frances, Shorter, Gillian, Starling, Bella, Williams, Hywel, Willis, Andrew, Witham, Miles D. and Treweek, Shaun 2022. Trial Forge Guidance 3: randomised trials and how to recruit and retain individuals from ethnic minority groups- practical guidance to support better practice. Trials 23 , 672.

Preview

PDF - Published Version Available under License Creative Commons Attribution. Download (1MB) | Preview

Abstract

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.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine Centre for Trials Research (CNTRR)
Additional Information:	This article is licensed under a Creative Commons Attribution 4.0 International License
Publisher:	BioMed Central
ISSN:	1745-6215
Date of First Compliant Deposit:	20 July 2022
Date of Acceptance:	16 July 2022
Last Modified:	14 May 2023 14:45
URI:	https://orca.cardiff.ac.uk/id/eprint/151374

Actions (repository staff only)

Edit Item