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.
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.
| Original language | English |
|---|---|
| Article number | 672 |
| Pages (from-to) | 1-12 |
| Journal | BMC Trials |
| Volume | 23 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 17 Aug 2022 |
Bibliographical note
Funding Information:We would like to thank the public contributors Emily Lam, Chandrika Kaviraj, Frida Malik, Saiqa Khan, Sonal Bhavsar, Philip Bell, Shareen Akhtar, Saadia Malik, Emdad Islam and Mahabuba Rahman who discussed our draft guidance at an online meeting hosted by Vocal (https://www.wearevocal.org ; via BS) held on 4th October 2021. We would also like to thank Rosilda Panoni, In-Trans Coordinator at the Grampian Regional Equality Council for providing the guidance document on working with interpreters and one of the budget examples included in Supplementary File 1. The Health Services Research Unit at the University of Aberdeen receives core funding from the Chief Scientist Office of the Scottish Government Health Directorates.
Funding Information:
The public contributor work was funded by Trial Forge via the Health Research Board Trial Methodology Research Network (HRB-TMRN) grant HRB-TMRN-2017-2. All of other work was done without dedicated funding. KK is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration East Midlands (ARC EM) and the NIHR Leicester Biomedical Research Centre (BRC).
Funding Information:
We would like to thank the public contributors Emily Lam, Chandrika Kaviraj, Frida Malik, Saiqa Khan, Sonal Bhavsar, Philip Bell, Shareen Akhtar, Saadia Malik, Emdad Islam and Mahabuba Rahman who discussed our draft guidance at an online meeting hosted by Vocal ( https://www.wearevocal.org ; via BS) held on 4th October 2021. We would also like to thank Rosilda Panoni, In-Trans Coordinator at the Grampian Regional Equality Council for providing the guidance document on working with interpreters and one of the budget examples included in Supplementary File . The Health Services Research Unit at the University of Aberdeen receives core funding from the Chief Scientist Office of the Scottish Government Health Directorates.
Publisher Copyright:
© 2022, The Author(s).