In a letter to the National Institute of Health (NIH) Director, Francis Collins, Food and Drug Administration (FDA) Commissioner, Stephen Hahn, and the Department of Health and Human Services (HHS) Secretary, Alex Azar, Representatives Moore, Karen Bass, Chair of the Congressional Black Caucus, and Robin Kelly, Chair of the Congressional Black Caucus Health Brain Trust called for stronger efforts to ensure diverse participants in clinical trials for a potential COVID-19 vaccine. The Members released the following statement:
“During this pandemic, inequities have been laid bare in Milwaukee and around the country. I supported funding for a vaccine in the previous COVID-19 relief packages, and it’s critical that these efforts ensure that clinical trials are diverse and inclusive and that participants are reflective of those whom COVID-19 has disproportionately impacted.”
In just the latest example, research released just this week by the Tufts Center for the Study of Drug Development again found that women, blacks, and Hispanics participate in clinical trials at rates below their share of the U.S. population. That studied examined about 370 clinical trials for new drugs and biologics approved for sale in the U.S. from 2007 through 2017. According to the study, participation of African Americans was 65% below their levels in the general population in these studies while women were underrepresented by 7.3%.
“My colleagues and I are calling on the NIH, FDA, and HHS to make efforts to reach communities who have been historically underrepresented in clinical trials to help find a vaccine that will keep every American safe and healthy,” said Congresswoman Gwen Moore (WI-04).
“The impact of COVID-19 on the Black community in America has been devastating. It is welcoming that efforts to produce a vaccine are underway however, we must also ensure that clinical trials are inclusive and protective of participants. African Americans have had a history of being excluded from clinical trials. In addition to assuring an inclusive and safe trial period of the new vaccine, accessibility and affordability of the vaccine must also be prioritized to allow the most vulnerable communities receive this critical treatment.” Congresswoman Karen Bass (CA-37), Chair of the Congressional Black Caucus.
“Ensuring that people of color are represented in clinical trials is critical to understanding the medicine under investigation. We live in a diverse world. When our clinical trials reflect that diversity, we get the best results and ensure vaccines work for the largest number of people,” said Congresswoman Robin Kelly (IL-02), Chair of the Congressional Black Caucus Health Brain Trust.
In the letter, the Members urge the agencies to create incentives or mandates for trial sponsors to include underrepresented groups, to create real time system to track diversity in ongoing clinical trials, to ensure that research funds go to a diverse group of researchers who can help reach underrepresented groups, and support a public awareness campaign to help increase participation by underrepresented populations.
The full text of the letter can be found here.