Lessons learned for future clinical development
COVID-19 disease, COVID-19 illness
EVENTS
The challenges experienced during the execution of the COVE enrollment strategy yielded important lessons about effective measures to achieve equitable representation among study participants that helped inform enrollment strategies for TeenCOVE and KidCOVE. Specifically, despite the vetted protocol design, site selection, and clear plan to enroll participants across the intended treatment population, the initial enrollment strategy of the COVE trial fell short in enrolling Black and Hispanic individuals. The precise underlying reason is multifaceted and could include increased fear of exploitation within these communities, which may have been exacerbated by the social unrest of events in 2020. After Moderna, Inc., became aware of the insufficient enrollment of Black and Hispanic individuals, all efforts were made to mobilize a data-directed, multipronged strategy to address the observed racial and ethnic discrepancies, which included utilizing registries and strategic satellite sites as well as adding sites with established means to recruit underrepresented minorities.It is essential that the data collected in clinical studies on COVID-19 vaccines such as mRNA-1273 can be reflective of entire populations, especially those at high risk of severe COVID-19 illness. The COVID-19 pandemic has disproportionately affected Black, Hispanic, and Native American populations who suffer from greater COVID-19–related morbidity and mortality than White Americans. Importantly, these disparities among racial and ethnic minorities do not appear to be due to a genetic predisposition to severe COVID-19 disease; rather, the same inequalities in the US healthcare system that have led to increased rates of underlying medical conditions, which also correlate with socioeconomic status, are shown to be risk factors for severe COVID-19 (Moving forward, the healthcare industry must continue to allocate resources to empower and build trust among diverse communities at a grassroots level. Mistrust as well as lack of knowledge or awareness of clinical trials and their importance have been previously identified as critical barriers to diverse clinical trial representation (In the midst of developing a COVID-19 vaccine in an unprecedented time, Moderna rapidly addressed initial enrollment challenges to refocus their strategy and ensure equitable representation in the final study population. As a result of these initiatives, healthcare professionals and patients can better understand the safety and efficacy of the vaccine in diverse populations. Moreover, vaccine efficacy data by demographic population are also available (This level of commitment to moral and scientific integrity highlights the real possibilities for patients and public health if industry leaders advocate for equitable healthcare. The pharmaceutical industry is encouraged to hold itself accountable to enroll the entire spectrum of intended treatment population in clinical trials, to perform rigorous safety and efficacy analyses by patient demographics, and to share the data in plain language with the public. These are foundational steps toward engaging with communities to foster trust and empowering people with the knowledge to make informed treatment decisions in partnership with healthcare professionals.