TrialSite has reported on news around the nation that at least some of the pivotal Phase 3 vaccine studies are struggling to enroll sufficient numbers of minority participants, particularly African Americans and Hispanics. Just recently in New Jersey, for example, TrialSite reported that the Mayor of Newark and the head of University Hospital moved to quell concerns in the Black community about Moderna’s COVID-19 vaccine trial. With considerable public investment in COVID-19 clinical trials, government funders emphasize the importance of diverse participation. Why? Because of a number of factors, including the social determinants of health, the risk of COVID-19 infection appears higher in communities of color as well as other at-risk segments, such as the elderly in long-term care facilities or individuals with certain comorbidities. Emphasizing the importance of diverse volunteer involvement, Moderna communicates to trial site organizations to focus on minority and at-risk volunteer recruitment, even at the expense of the speed of the clinical trial.
Social Determinants of Health & Pandemic
Due to a number of factors, including the social determinants of health, the risk of COVID-19 infection appears higher in some communities over others. The CDC recently reported on the increasing evidence that at least certain racial and ethnic groups face higher COVID-19 infection rates. Some studies reveal Black males are infected at higher rates than other groups. Other studies revealed Blacks are infected at far higher rates but death rates appear to include class (e.g. income, education levels, etc.) factors. COVID-19 infection rates in New York were found to have a clear correlation of volume of positive COVID-19 testing results in Black and Hispanic districts in the city. That the elderly are vulnerable, especially males with comorbidities, is well documented.
According to one research endeavor, Blacks and Hispanics (Latinos) are three times as likely to be infected by COVID-19.
As highlighted by the CDC, “Inequities in the social determinants of health, such as poverty and healthcare access, affecting these groups are interrelated and influence a wide range of health and quality-of-life outcomes and risks.”
Government Mandate for Trial Diversity
Blacks make up about 13% of the U.S. population, yet only 5% of clinical trial participants, according to a recent New York Times article. Similar trends occur with Hispanics and other at-risk groups, including the elderly. TrialSite’s “African American Clinical Research Disparity Survey” highlights some of the challenges of subject engagement.
As the U.S. government invests billions into COVID-19 research, including the imperative established by Operation Warp Speed, public mandates matter. In response to the unprecedented public health crisis of COVID-19, the National Institutes of Health (NIH) established Accelerating COVID-19 Therapeutic Interventions and Vaccines or ACTIV, a public-private partnership to develop a coordinated research strategy for prioritizing and accelerating therapies and vaccines targeting SARS-CoV-2. Diverse participation in COVID-19 trials represents a critical variable in successful publicly financed trials. In an interview with Lloyd Minor, Dean of the Stanford School of Medicine, Dr. Anthony Fauci highlighted the importance of minority participation in COVID-19 studies, for example.
The ‘COVE Study’
The U.S. Government is a co-sponsor in the pivotal COVE Study investigating the efficacy of the experimental vaccine called mRNA-1273. Specifically, co-sponsors include the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID).
Consequently, Moderna has benefited from over $900 million in public investment during this pandemic. The drug developer has a target of 30,000 volunteers for the Phase 3 COVE trial. The Cambridge, MA-based biotech has made diversity a central theme. Almost 100 trial site locations were selected for the study, identified and recruited in part to increase the probability for diverse participation in this pivotal study. The sponsor, of course, must count on the trial site organization to engage the local communities to drive home the importance of vaccine participation.
On August 23, TrialSite reported that NIH Director Francis Collins assigned Moderna a “C” for its results thus far in association with minority participation.
As of Friday, September 4, the sponsor reports diversity a total of 21, 411 in the COVE study; approximately 26% of the participants are members of diverse communities. This falls short of the targets mandated by the three sponsors (again Moderna, BARDA and NIAID).
The U.S. Hispanic population is over 61 million, representing at least 18.5% of the nation’s population with Blacks accounting for 13%. Moderna doesn’t breakdown their “diverse communities” numbers for the public but clearly, based on various news sources and comments from important government research leadership, the company must work with trial site organizations to intensify community outreach for greater minority involvement.
According to a recent Yahoo News article, almost 20% of the 11,000 enrolled thus far in the Pfizer/BioNTech COVID-19 vaccine Phase 3 trial are from Black and Hispanic populations.
Trust is the Key Ingredient for Engagement
With a rapidly diversifying population, sponsors—whether public or private—must find ways to develop greater trust with different demographics. TrialSite now approaches the one million viewers per month metric and, based on analysis of feedback and various interactions over the past year, it’s clear that trust in the pharmaceutical industry (and for that matter, the government research apparatus) is at a low point for many segments of American society. TrialSite exists to not only track, monitor and report on clinical trials in an objective and unbiased manner but also facilitate engagement with all populations interested in research. For example, TrialSite has formed a partnership with a major research-focused U.S. public-private partnership to bolster engagement in minority communities, among other things. Trust is a key ingredient for engagement and because TrialSite represents not only an independent media platform that focuses on research transparency and accessibility, but also a business that doesn’t process and sell viewer aggregate information, the traffic continues to grow while the opportunity for engagement thrives. Improved health care in the United States (and elsewhere) requires the coming together of different stakeholders and a transformation of the health care system known today.