Warner, Senate colleagues call for diversity in COVID-19 pharmaceutical trials
U.S. Sen. Mark Warner joined a group of Senate colleagues in urging pharmaceutical companies engaged in COVID-19-related work to prioritize diversity in any coronavirus vaccine or trial.
Given the disproportionate impact of the outbreak on communities of color and other minority groups, the senators requested that any vaccine or therapeutic drug trial related to COVID-19 includes women, minorities, and LGBTQ+ persons. They also underscored the critical need for comprehensive demographic and racial data to ensure that new treatments work for all Americans.
“The disparities in the COVID-19 pandemic are exacerbated by higher rates of chronic disease among many minority populations, inequitable access to health care, and bias within the health care system itself. As such, any clinical trials for vaccines and therapeutic treatments of COVID-19 must include participants that racially, socioeconomically, and otherwise demographically represent the United States,” wrote the senators. “This virus is striking in its disproportionate impact on minority populations, and it more important than ever that these populations are represented in any clinical trials.”
“The FDA alone cannot fix the problem of underrepresentation. The private sector must also take proactive steps to ensure drug and vaccine trials include a diverse group of Americans,” the senators continued. “We urge you to examine new and creative ways to enroll a diverse set of participants in COVID-19-related trials such as reducing barriers to clinical trials, utilizing diverse clinical trial personnel, ensuring language accessibility, and investing in participant recruitment by partnering with minority health and community advocacy groups.”
In letters to the CEOs of Abbot Labs, Abbivie, Amgen, Astra Zeneca, Bayer, CSL Behring, Eli Lilly, Genetech, Gilead, GSK US, Johnson & Johnson, Novartis, Pzifer, Regeneron, Sanofi and the Biotech Innovation Organization (BIO), the Senators also underscored that the disparities in the COVID-19 pandemic for many minority populations are exacerbated by higher rates of chronic disease, inequitable access to health care, and bias within the health care system itself.
The senators also cited “alarming” research showing that, while African Americans represent 12 percent of the national population, they make up only 5 percent of all clinical trial participants. The numbers for Hispanics are even more stark at 16 percent and 1 percent, respectively.