Letter to The Honorable Alex M. Azar, Secretary of Health and Human Services, The Honorable Francis Collins, Director of National Institutes of Health, and The Honorable Stephen M. Hahn, Commissioner of Food and Drug Administration - Representatives Moore, Bass, and Kelly Call for Diversity in Clinical Trials for Potential COVID-19 Vaccines

Letter

Dear Secretary Azar, Director Collins, and Commissioner Hahn
As you work to develop a vaccine in response to the novel coronavirus, we urge you to
proactively take steps to ensure that all related clinical trials are diverse and inclusive, especially
given COVID-19's disproportionate impact on communities of color. We must also ensure the
vaccine or other COVID-19 treatments are affordable so that all communities can benefit. I urge
you to work with all relevant federal agencies (such as the Food and Drug Administration) and
other key stakeholders (researchers, medical professionals, pharmaceutical industry, minority
health organizations, etc.) to achieve these goals.
Science's ability to develop new treatments and medical knowledge hinges on rigorous and
generalizable clinical trials. In the spirit of the NIH Revitalization Act of 1993 and as noted by
the Food and Drug Administration, "medical products are safer and more effective for everyone
when clinical research includes diverse populations." Unfortunately, vulnerable populations have
long been underrepresented in medical research despite being disproportionately affected by
many of the studied diseases--this extends to the current COVID-19 crisis. Specifically, racial
and ethnic minorities make up roughly 40% of the U.S. population (African Americans
specifically represent about 13% of the population), yet these groups have never come close to
that representation in crucial clinic trials. Studies that do not reflect the full diversity of the
United States may yield treatments that do not help, and may in fact harm, large segments of our
population. These oversights are inexcusable, especially as COVID-19 ravages minority
communities.
Reported barriers to minority group's participation include lack of awareness (including
language barriers), access to healthcare, and distrust of the medical community. Patient travel
and accommodations costs and logistics during trials represent another barrier. Yet these
obstacles are not insurmountable with the right incentives and leadership. This pandemic offers
us a fresh opportunity to work to correct the historic inequalities of past research efforts.
In the four coronavirus related funding bills enacted to date, U.S. taxpayers provided billions of
dollars to support vaccine and treatment development. Consequently, we must ensure that all
Americans benefit from the eventual treatments by ensuring a diverse study population. To meet
this goal, we ask that HHS, NIH, and FDA undertake the following actions:
- Incentives/Mandates for Minority Participation- Ensure that the participants in
COVID-19 clinical trials fully represent the populations being hit the hardest by this
virus. This can be done by either creating incentives or mandates for clinical trial
sponsors (researchers, drugmakers) to take all necessary take steps, to ensure proportional
inclusion of underrepresented groups, specifically participants from minority
communities in a culturally appropriate and sensitive way. Within 30 days, please
respond to this letter with the specific methods NIH and FDA currently use to achieve
diversity in federally-funded trials, data on current diversity within COVID-19 trials, and
proposals for how to improve.
- Real-Time Data & Response Plan- Implement systems for real-time tracking of
diversity and inclusiveness in such trials. This data should be made publicly available and
updated at least monthly. For any identified representation gaps, develop a strategic plan
to enhance participation from underrepresented groups in a timely manner (30 days).
Submit this plan to Congress and/or the Tri-Caucus (Congressional Black Caucus,
Congressional Hispanic Caucus, and the Congressional Asian Pacific American Caucus)
within 60 days.
- Funding for Disparities Research and Diverse Grantees- Augment funding for and
fast track applications for research on the impact of COVID-19 on minority communities,
both in terms of physiology and social determinants of health. These funds should also be
granted to a diverse group of principal investigators and institutions (HCBUs, etc). As
noted by one expert, "if you have trusted health care providers in your community who
look like you, are culturally relevant, and understand the challenges associated with those
communities, it helps to foster trust as well as promote the practice of medicine.1" Within
30 days, please respond with the specific methods NIH and FDA currently use to achieve
diversity among its grantees and data on the current diversity of awardees. Please also
provide the raw number and percent of NIH COVID-19 grants that address disparities or
minority health.
data: November 21, 2019
- Public Awareness- Conduct a public awareness campaign, using the press, communitybased organizations, and faith-based communities, to ensure affected communities
understand the available research opportunities and the importance of participation.
Funding for participants' transit and accommodations to participate in trials should also
be provided on a needs-basis.
- Affordability- Work with the pharmaceutical industry and vaccine makers to ensure the
affordability of all COVID-19 treatments. Publicly share all research and development
costs for therapies that received public funding.
If we fail to enact the above efforts, minority communities run the risk of being sidelined in the
race to find treatments for COVID-19, and our therapies and our nation will suffer for it.
Therefore, as the scientific community rises to meet the virus, we must guarantee that our
research efforts do not perpetuate societal inequalities, nor in our haste that we abandon our
American values of health equity and diversity. Rather we must ensure that all communities,
especially the communities of color disproportionately suffering from the virus, are fully
represented in this vital work.