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 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.

How do trial teams plan for retention during the design stage of the trial? A scoping review

“…The Health Research Board in Ireland also recommends working with PPI colleagues in the research it funds. We also direct trial teams to read Trial Forge Guidance 3 which is available as an open access document, to ensure they are taking steps to help recruit and retain individuals from under-served groups and that members of these groups are included in PPI groups (43).…”

Strategies to Improve Adherence to Skin Self-examination and Other Self-management Practices in People at High Risk of Melanoma

“…This may have unintentionally limited diversity in trial populations, contributing to underrepresentation of groups, such as those who are socioeconomically disadvantaged. Codesign with community members of underserved groups may identify ways to improve trial process to increase diversity of trial populations and applicability of evidence generated . Although all trials used intervention design as a strategy, very few used codesign methods for the intervention or trial design, and a minority of trials incorporated end-user testing of the intervention before the trial.…”

“…Codesign with community members of underserved groups may identify ways to improve trial process to increase diversity of trial populations and applicability of evidence generated. 43,44 Although all trials used intervention design as a strategy, very few used codesign methods for the intervention or trial design, and a minority of trials incorporated end-user testing of the intervention before the trial. All trials provided participant support in the form of educational materials, with information often delivered in more than 1 mode, but only a minority used behavioral or motivational strategies (reminders, clinician reinforcement and feedback, priority-setting exercises, and/or action plans).…”

Participant characteristics and exclusion from trials: a meta-analysis of individual participant-level data from phase 3/4 industry-funded trials in chronic medical conditions

“…Women, older people, people with multi-morbidity and those from ethnic minorities ("underserved populations") are inadequately represented in trials [1][2][3][4][5][6] . This systematic underrepresentation undermines the generalisability of trial findings and confidence in the selection of optimal treatment strategies for these groups [7][8][9][10][11] .…”