An initial lag in racial and ethnic group enrollment and subsequent revision of the recruitment strategy to ensure equitable representation
RECRUITMENT
The first participant was enrolled into the COVE study on July 27, 2020, at 6:00 Discussions with study sites were initiated to understand the potential reasons for low daily enrollment of racial and ethnic minorities despite initial site selection data indicating enrollment of these groups was feasible. COVE investigators indicated to Moderna that the social and political unrest in the United States during the summer of 2020 augmented deep-rooted fear and distrust of the government, the pharmaceutical industry, and clinical trial sites within historically underrepresented populations. These issues ultimately manifested as increased hesitation to enroll into the COVE study, highlighting health disparities and underpinning the need to address health equity within the drug development process.To tackle these specific enrollment hurdles facing racial and ethnic minorities in the COVE study, a Diversity and Inclusion Advisory Committee comprised of members from the National Institutes of Health, Operation Warp Speed, faith-based leaders, the CoVPN, and the US Department of Veterans Affairs was established. The committee was tasked to review race and ethnicity enrollment demographics on a weekly basis, review current community outreach activities and outcomes, develop strategies to ensure all communities significantly impacted by COVID-19 were participating, and support development and implementation of participant retention strategies (Enrollment data were also utilized to rapidly revise the recruitment strategy to ensure equitable representation among the COVE study population. Enrollment metrics were monitored daily, with transparent and regular updates shared with study sites regarding current enrollment objectives and metrics, in addition to changes in the enrollment strategy. Weekly calls that highlighted data from enrollment dashboards also aided recruitment efforts, with site personnel commenting that these dashboards provided a highly useful level of data granularity not previously seen. Dashboards were also key to raising awareness since they included a snapshot of how each site’s enrollment data compared to local census data. This approach cultivated shared accountability among the sites.In addition, meetings were held with public health authorities and Moderna to speak with the study sites on multiple occasions to provide encouragement and reinforce the importance of achieving a dataset that was representative of the US population. Moderna provided sites with training on conscious inclusion to ensure a full understanding of barriers to minority enrollment and prepared sites for engagement in complex, culturally-sensitive conversations to address concerns among potential African American and Latinx trial participants.Ultimately, delineating these expectations and establishing open communication with the COVE study sites helped to quickly change the recruitment strategy in order to address those initial challenges that hampered an appropriately diverse study population. This revised strategy encompassed multiple key aspects that together ensured equitable representation in the COVE trial. One tactic was to leverage clinical trial registries of individuals who previously provided self-identified race and ethnicity information and who had pre-consented to receive information regarding COVID-19 clinical trials. One such registry, CoVPN, was used by 60 of the 99 sites. In addition, Moderna, Inc., partnered with a network of patient-recruitment companies, trusted national pharmacy networks, healthcare organizations, and patient advocacy groups to recruit individuals from diverse backgrounds.A third aspect of the revised strategy was to add 10 additional study sites in late August 2020, and Moderna, Inc., also encouraged the establishment of CoVPN satellite sites, such as the nonprofit Casa de Maryland in Baltimore that was headquartered in an epicenter of the COVID-19 pandemic and had a strong relationship with the local community. Further, site-facing materials were revamped for participant inclusivity from diverse populations, and new materials were created and translated into Spanish to support study staff’s continued focus on clinical trial diversity. Finally, study sites collaborated with local community leaders to disseminate additional information on a local level to dispel widespread rumors and misinformation regarding the mRNA-1273 investigational vaccine.To further ensure that the final COVE trial population reflected US demographics, Moderna made the necessary decision in early September 2020 to slow enrollment of White participants to allow for adequate enrollment of underrepresented individuals. Although this decision slowed the pace of enrollment, Moderna and the US government understood that achieving a diverse study population was essential to ensure a more robust and representative body of clinical knowledge and build confidence in the generalizability of the safety and efficacy data collected in the COVE study. This adjustment to the enrollment strategy proved invaluable in ensuring the final COVE study population was representative of US demographics. The combination of these strategies, along with the unwavering commitment of the investigators and operations teams to extend the enrollment opportunity to historically underrepresented populations, and provide the information needed to make an informed decision, led to increased representation of Black and Hispanic/Latinx participants (Participant demographics in the COVE, TeenCOVE, and KidCOVE studies. 