Congressional Leaders Urge NIH, FDA, and HHS to Ensure Diverse Participation in COVID-19 Vaccine Trials

Strategic Insights -

Congressional leaders from the Black Caucus have issued a statement and letter to the National Institute of Health (NIH), Food and Drug Administration (FDA), and Department of Health and Human Services (HHS) Secretary Alex Azar, urging them to ensure diverse participation in COVID-19 vaccine trials. The leaders express concern that the current clinical trials lack diversity, which could result in treatments that do not help, and may harm, large segments of the population.

Key Takeaways:

  • The Congressional Black Caucus has called for stronger efforts to ensure diverse participants in COVID-19 vaccine trials, citing the disproportionate impact of the virus on communities of color.
  • Research has shown that women, blacks, and Hispanics participate in clinical trials at rates below their share of the U.S. population, with African Americans being 65% underrepresented in these studies.
  • Members of Congress have urged the NIH, FDA, and HHS to create incentives or mandates for trial sponsors to include underrepresented groups, create a real-time system to track diversity in ongoing clinical trials, and ensure that research funds go to a diverse group of researchers.
  • The leaders have also asked the agencies to implement measures to make COVID-19 treatments affordable, particularly for vulnerable communities, and to conduct a public awareness campaign to increase participation by underrepresented populations.
  • The letter specifically requests that the agencies respond within 30 days to the Congressional letter with the current methods for achieving diversity in federally-funded trials, data on current diversity within COVID-19 trials, and proposals for improvement.
  • The Congressional leaders have also requested that the agencies augment funding for research on the impact of COVID-19 on minority communities and grant funding to a diverse group of principal investigators and institutions.

Statistics:

  • According to the Tufts Center for the Study of Drug Development, women were underrepresented in clinical trials by 7.3%, while participation of African Americans was 65% below their levels in the general population in these studies.
  • Racial and ethnic minorities make up roughly 40% of the U.S. population, yet these groups have never come close to that representation in crucial clinical trials.
  • Estimated barriers to minority group participation in clinical trials include lack of awareness, access to healthcare, language barriers, patient travel and accommodations costs, and distrust of the medical community.
  • The Congressional leaders have also urged the agencies to publicly share all research and development costs for therapies that received public funding to ensure affordability.

Sources:

  • Congresswoman Gwen Moore (WI-04) press release
  • Congressional Black Caucus Health Brain Trust press release
  • May 13, 2020 Letter to Secretary Azar, Director Collins, and Commissioner Hahn
  • Tufts Center for the Study of Drug Development study on clinical trial diversity
  • National Institutes of Health (NIH) Revitalization Act of 1993