U.S. Rep. Larry Bucshon (R-IN) recently introduced a bipartisan bill to improve diversity in clinical trials and data collection for COVID–19 and future public health threats.
“As a doctor, I know firsthand how critical it is to have the most accurate data and information to provide patients with the care they need,” Rep. Bucshon said on Monday. “In order to do that successfully, ensuring that clinical trials for vaccines, drugs and treatments adequately represent all demographics is critical.”
Rep. Bucshon on Aug. 13 introduced the Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act, H.R. 5030, with bill sponsor U.S. Rep. Raul Ruiz (D-CA). U.S. Sens. Tim Scott (R-SC) and Bob Menendez (D-NJ) on Aug. 10 introduced the companion bill, S. 2706, in their chamber.
If enacted, the bill would allow the U.S. Department of Health and Human Services (HHS) to issue grants or enter into contractual arrangements to support education, outreach and recruitment for clinical trials for diseases having a disproportionate impact on underrepresented populations, according to a bill summary provided by Rep. Bucshon’s staff.
“The DIVERSE Trials Act will help promote clinical trials having proportionate representation of all communities of color as well as support education, outreach and recruitment for future clinical trials,” said Rep. Bucshon.
Additionally, the measure would build on the CARES Act data collection requirements to improve collection of demographic data on COVID-19, including social determinants of health; and create a statutory safe harbor for patient support that can be the critical factor for some lower-income patients in deciding whether to participate in a trial, such as the ancillary costs of transportation or childcare, the summary says.
“One of the many reasons communities of color have historically low vaccination rates is because they are underrepresented in the clinical trials process,” said Sen. Scott. “Too often, these clinical trials fail to recruit an adequate number of diverse participants leading to low confidence in vaccines among underrepresented groups. The DIVERSE Trials Act will help to ensure we are one step closer to bridging the racial disparity gap.”
The American Cancer Society Cancer Action Network, the National Health Council, and the We Must Coalition support the legislation.