Rep. Kelly introduces bipartisan, bicameral bill to increase diversity in clinical trials

WASHINGTON - U.S. Rep. Robin Kelly (IL-02) introduced the bipartisan and bicameral NIH Clinical Trial Integrity Act to increase the diversity of participants in clinical trials funded by the National Institutes of Health. This bill is also led by U.S. Rep. Brian Fitzpatrick (R-PA) and U.S. Senators Andy Kim (D-NJ) and Susan Collins (R-ME).

"When people are excluded from clinical trials, they are also excluded from treatments for chronic diseases. The data clearly lays out the fact that historically marginalized communities disproportionately suffer from certain illnesses and diseases - but we are excluded from clinical trials," said Rep. Kelly, Chair of the CBC Health Braintrust. "I'm proud to work with my colleagues across the aisle and in the Senate to ensure better representation in our clinical trials. No one should be left behind in the pursuit of medical breakthroughs."

"Medical breakthroughs are only as strong as the data behind them-and data that excludes entire communities is incomplete by definition," said Representative Fitzpatrick. "The NIH Clinical Trial Integrity Act strengthens the integrity of our research by ensuring clinical trials reflect the full diversity of the patients they are meant to serve. This bipartisan, bicameral effort is about inclusion, accountability, and better science-so that lifesaving treatments work for everyone."

"Biomedical research holds tremendous promise for treating many of the most costly and devastating diseases we face. To ensure that the benefits of cutting-edge medical science reach all Americans, it is important that participants in clinical trials reflect our overall population," said Senator Collins. "By encouraging long-term planning and improving demographic representation in clinical studies, this bipartisan legislation would help enhance the effectiveness of critical research that is conducted and sponsored by the NIH."

"We have a responsibility to ensure Americans of all backgrounds have fair and equal access to treatment and care. This needs to begin with fair and equal representation in the earliest stages of health research and testing, including clinical trials," said Senator Kim. "I hope we can come together to use this legislation as a tool to combat dangerous and persistent health inequities that are putting communities of color and diverse backgrounds at-risk."

The NIH Clinical Trial Integrity Act will:

• Require NIH to work with clinical trial sponsors to develop clear and measurable recruitment and retention goals based on disease/condition prevalence as well as a rationale for specified goals and a recruitment plan;
• Ensure the availability of less burdensome follow-ups during clinical trials (e.g. fewer follow ups, phone participation, weekend hours) to increase participation of underrepresented populations;
• Launch a public awareness campaign across federal agencies related to research participation opportunities.

The bill has been endorsed by the Association of Black Cardiologists, Patient Access Network (PAN) Foundation, Blood Cancer United, Susan G. Komen Foundation, American Psychological Association, National Organizations for Rare Disease (NORD), TOUCH: The Black Breast Cancer Alliance, Doctors for America.

Read the full bill text here.