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

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 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. Make sure your trial materials are developed with inclusion in mind; 3. Ensure staff are culturally competent; 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.