Diversity and inclusion in clinical trials: Evolution throughout the development of an mRNA COVID-19 vaccine

Abstract

Despite the importance of equitable representation in clinical trials, disparities persist with racial and ethnic minorities remaining largely underrepresented in trial populations. During the coronavirus disease 2019 (COVID-19) pandemic, wherein disease disproportionately affected racial and ethnic minority groups, the necessity for diverse and inclusive representation in clinical trials has been further highlighted. Considering the urgent need for a safe and efficacious vaccine, COVID-19 vaccine clinical trials faced marked challenges in rapidly enrolling participants without forgoing diverse representation. In this perspective, we summarize Moderna’s approach toward achieving equitable representation in mRNA-1273 COVID-19 vaccine clinical trials, including the COVID-19 efficacy (COVE) study, a large, randomized, controlled, phase 3 trial of mRNA-1273 safety and efficacy in adults. We describe the dynamics of enrollment diversity throughout the COVE trial and the need for continuous, efficient monitoring and rapid pivoting from initial approaches to address early challenges. Insights gained from our varied and evolved initiatives provide key learnings toward achieving equitable representation in clinical trials, including establishing and listening to a Diversity and Inclusion Advisory Committee, repeatedly engaging with key stakeholders on the necessity for diverse representation, creating and disseminating inclusive materials to all trial participants, establishing methods to raise awareness for interested participants, and enhancing transparency with trial participants to build trust. This work shows that diversity and inclusion in clinical trials can be attained even in the most extreme circumstances and highlights the importance of efforts toward building trust and empowering racial and ethnic minorities with the knowledge to make informed medical treatment decisions.

Ending Race-Conscious College Admissions and Its Potential Impact on the Infectious Disease Workforce

“…The immeasurable contribution of ID physicians was clearly demonstrated during the COVID-19 pandemic during which ID clinicians and researchers led multifaceted efforts of the pandemic response, including the development of vaccines that not only saved millions of lives, but importantly reduced hospitalizations and overall healthcare expenditures [ 34 , 35 ]. Despite the absence of ID physicians in 80% of U.S. counties [ 36 ], this underrepresented contingent of the ID workforce led the recruitment of diverse participants in COVID-19 vaccine clinical trials [ 37–39 ], and the vaccine uptake increase among minoritized communities [ 40 , 41 ].…”

Social determinants of health inequalities in early phase clinical trials in Northern England

“…However, a significant proportion of patients had ethnicity 'unknown' (Newcastle n = 64, 17.5%; Manchester n = 400, 45.6%), which due to retrospective data collection was not possible to confirm. It is recognised that patients from minority ethnic backgrounds in the UK are less likely to participate in clinical research, as demonstrated through COVID-19 vaccine development, and improving access to studies is a National Institute for Healthcare Research (NIHR) priority [23][24][25]. Capturing ethnic diversity more comprehensively is of particular importance in early phase cancer trials due to the increasing number of molecularly guided interventional studies and the divergence in molecular target prevalence between ethnicities.…”