Research equity in the PRINCIPLE and PANORAMIC national community COVID-19 Clinical Trials

Problem

Background: Underserved, and Black, Asian and Minority Ethnic (BAME) communities are often underrepresented in clinical trials – the very communities whom Covid-19 disproportionately and adversely affected. Lack of participation is often due to:

· Culturally inappropriate and ineffective communication

· Minimal co-creation of messaging and engagement strategies

· Lack of awareness

· Difficulty in accessing research

· Mistrust, influenced by faith, belief and previous experiences.

Approach

Aim: To ensure recruitment into two national Covid-19 treatment trials, PRINCIPLE and PANORAMIC, were representative of the wider population in terms of deprivation and ethnicity, we:

· Appointed a national pharmacist expert to engage BAME and communities with high social deprivation about participation

· Co-created community outreach programmes with national and regional religious and community organisations

· Collaborated with universities and students in areas of high deprivation and concentrated BAME populations to engage their local communities

· Developed and distributed, accessible, culturally appropriate and user-friendly materials in many languages

· Engaged national professional and charitable healthcare institutions and organisations

· Distributed materials and raised awareness through national pharmacy organisations and all major pharmacy multiples

· Appeared on local and national social and other media channels, including Asian radio and national television platforms.

Findings

Outputs:

· PRINCIPLE became visible in > 8,500 community pharmacies

· Places of worship (e.g. mosques and temples) and religious leaders encouraged people to join the trials (3-fold increase in website hits after one initiative).

· Students from the University of Bolton learned about the trial, and wearing trial hoodies, engaged local residents in malls, places of worship, and in other community organisation in a 3-year program.

The azithromycin comparison included 55 (4·0%) South Asian and seven (0·5%) Black participants (vs. 3·7% Asian ethnicity and 1·6% Black ethnicity among people aged 50 + in England and Wales). Proportions of participants in Index of Multiple Deprivation (IMD) quintiles were: 352 (26%) of 1375 in IMD1 (least deprived); 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.

Consequences

Building on learnings from PRINCIPLE, PANORAMIC became the fastest recruiting trial ever of an acute therapeutic agent, with 26,411 randomised within 4 months, including 1507 from ethnic minority backgrounds in the sample from England and Wales (800 Asian (3.22%), 153 Black (0.62%), 389 Mixed (1.57%), and 165 Other (0.66%), exceeding national proportions for many key indices.

Conclusion: The PRINCIPLE and PANORAMIC national UK trials achieved close to representative samples in relation to BAME and deprivation. Our outreach programs highlight the importance of research equity strategies that are multifaceted, flexible, co-created, and build upon previous experience and trusting relationships. Pragmatic clinical trials should embed inclusion strategies with dedicated investment early on.