We welcome the call from Paramjit Gill and colleagues1 for diverse participation in clinical trials like PRINCIPLE.2We initiated many inclusive recruitment strategies, including the appointment of a leading and national pharmacist expert working with minority ethnic communities who was tasked with targeting socioeconomically deprived areas, minority ethnic communities, and people with learning difficulties; developing UK-wide relationships with community and religious organisations (including places of worship); collaborating with universities and national and regional health-care institutions; and gathering nationwide support from minority ethnic leaders, health professionals, and their organisations (appendix).
We consistently promoted the trial in many languages, via local and UK national media channels, the internet, and social media platforms. Our pharmacy networks and general practice networks helped establish PRINCIPLE footprints in approximately 7500 community pharmacies UK-wide, with more than 1000 general practice co-investigators helping with participant recruitment from a range of settings.
This strategy contributed to the inclusion of 55 (4·0%) South Asian and seven (0·5%) Black participants in our analysis of azithromycin for treatment of suspected COVID-19,2 which was comparable to 3·7% Asian ethnicity and 1·6% Black ethnicity among people older than 50 years (PRINCIPLE's target age group) in England and Wales.3 The proportions of participants' in Index of Multiple Deprivation (IMD) quintiles were (from most to least socioeconomically deprived): 352 (26%) of 1375 in IMD1; 267 (19%) of 1375 in IMD2; 270 (20%) of 1375 in IMD3; 241 (18%) of 1375 in IMD4, and 245 (17%) of 1375 in IMD5. Overall, this shows good recruitment from socioeconomically deprived and minority ethnic communities.
PRINCIPLE's innovative approach now supports the recruitment of minority ethnic participants to other UK national trials. We recognise that our initial outreach strategy requires further and targeted investment, initiatives, collaboration, and institutional support to enable sustainable engagement of people from minority ethnic communities in primary care research, ultimately for inclusive, equitable health for all.
© 2021 Adaniel Leal-Olivas/Getty Images
We declare no competing interests. FDRH and CCB are joint corresponding authors.
Supplementary Material
References
- 1.Gill PS, Poduval S, Thakur JS, Iqbal R. COVID-19, community trials, and inclusion. Lancet. 2021;397:1036–1037. doi: 10.1016/S0140-6736(21)00661-9. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.PRINCIPLE Trial Collaborative Group Azithromycin for community treatment of suspected COVID-19 in people at increased risk of an adverse clinical course in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial. Lancet. 2021;397:1063–1074. doi: 10.1016/S0140-6736(21)00461-X. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Office of National Statistics UK population by ethnicity: England and Wales 2011 Census. 2018. https://www.ethnicity-facts-figures.service.gov.uk/uk-population-by-ethnicity/demographics/age-groups/latest#average-age-by-ethnicity
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.