Ethnic minority participation: what can drug companies do to increase enrollment in COVID-19 vaccine trials?
Anthony Salandy, Ph.D., M.S.
President and Executive Director
Dr. Salandy is founder of the Institute for COVID-19 Vaccination Advocacy (ICVA). ICVA aims to increase knowledge of the COVID-19 vaccination program, decrease COVID-19 vaccine hesitancy, and improve COVID-19 vaccine coverage around the globe.
Moderna and Pfizer/BioNtech continue their push to complete Phase III clinical trials of a COVID-19 vaccine. While, AstraZeneca’s COVID-19 vaccine Phase III clinical trials are on hold. All Phase III clinical trial studies have had a challenge in recruiting participants from diverse communities.
For instance, Moderna reported 27,321 had enrolled in the study as of 9/25/20. With 31% of participants enrolled cumulatively from diverse communities . The non-white population in the US is approximately 37%. Researchers argue that African Americans and Latinos have voiced their concerns about participating in the clinical trials specifically for the COVID-19 vaccine.
In the face of slow recruitment of “diverse communities’, pharmaceutical companies have not outlined in their study protocol what additional steps may be taken to expand recruitment outreach to diverse communities. Currently, much of the recruitment is occurring online.
However, Pfizer/BioNtech who reported 31,928 participants enrolled as of 9/21/2020 (26% being persons from ‘diverse communities’), proposed an expansion from 30,000 (initial target) to 44,000 study participants. This suggests that they have not reached the recruitment target for participants from diverse communities.
With over 200 COVID-19 vaccines currently under development, novel recruitment methods have to be used to reach recruitment targets in diverse communities. It would be prudent for pharmaceutical companies to partner with community-based organizations with the goals of disseminating accurate information about the clinical trials through intentional workshops and in-person meetings.
For example, Meharry Medical College is sending personal invitations to potential study participants to meet for informational seminars. They are ready to begin Phase II trials of the Novavax COVID-19 vaccine candidate.
Unique strategies and new partnerships to reach communities of color will be needed for any findings from COVID-19 vaccine trials to be interpreted with a great deal of certainty.