Improving inclusivity in UK clinical trials through good practice in the collection and use of ethnicity data: recommendations from the INCLUDED study.

Abstract

Ethnicity data are essential in understanding how different groups are impacted by different treatments/healthcare interventions, but more work is needed in how these data should be collected, handled and reported in trials to address distrust among marginalised ethnic groups towards healthcare research. To do this, researchers need effective training and opportunities to engage with communities from a diverse range of ethnicities. Developing guidance on how to meaningfully involve diverse ethnic groups in all stages of a trial including planning the collection of ethnicity data is one way to improve the impact of clinical trial results and ensure these groups can access equitable healthcare.Our collaborative work between health researchers and diverse ethnic communities produced 13 initial recommendations aimed at academic health researchers to change their practice involving diverse ethnic communities in areas from trial design through to reporting. The first four recommendations are concerned with the planning stage of the trial, the fifth with how researchers interact with funding bodies. Recommendations 6, 7 and 8 are relevant to data collection during trial set up, and recommendations 9, 10 and 11 focus on training and responsibility during the trial set up and the trial conduct stage. Recommendations 12 and 13 cover reporting.The recommendations will benefit from piloting but have the potential to help trial teams make their research more inclusive with regard to ethnicity, which in turn will support more representative, equitable and impactful research.