Ruiz Introduces DIVERSE Trials Act
Washington, D.C. – Today, Congressmen Raul Ruiz, M.D. (D-CA) and Larry Bucshon (R-IN) announced the introduction of bipartisan, bicameral legislation to improve access to and diversity in clinical drug and treatment trials. The Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Act 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 with a disproportionate impact on underrepresented populations. U.S. Senators Bob Menendez (D-NJ) and Tim Scott (R-SC) introduced companion legislation in the Senate.
“The disproportionate impact of the COVID-19 pandemic on communities of color has highlighted the urgent need for diverse participation in medical trials,” Dr. Ruiz said. “As a physician, I know firsthand how factors like race and associated social determinants of health can influence the effectiveness of different medications and therapies. That is why I am introducing the DIVERSE Trials Act, which will increase diversity in clinical trial participation through outreach to underrepresented populations. With this bipartisan, bicameral legislation, we will improve health outcomes and access to lifesaving vaccines, medications, and treatments.”
“For too long, communities of color have been underrepresented in clinical trials,” said Sen. Menendez. “As COVID-19 spread across the country and disproportionately hit densely populated minority communities, it became apparent that studies on lifesaving vaccines, drugs, and treatments must include people of all ethnic and racial backgrounds. This bill will help create more diverse clinical trials to improve the health of the nation.”
“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.”
“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. In order to do that successfully, ensuring that clinical trials for vaccines, drugs, and treatments adequately represent all demographics is critical,” said Dr. Bucshon. “The DIVERSE 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.”
Earlier this year, a report analyzing demographic data from ten years’ worth of clinical trials found that minorities were underrepresented relative to their proportion of the general U.S. population. This lack of diversity was highlighted last year when emergency-use authorizations were fast-tracked for a variety of COVID- 19 products. Even companies who tried to enroll people of color in those trials reported difficulties, despite the virus’s documented toll on communities of color.
The DIVERSE Act will:
- Require HHS to issue guidance on how to conduct decentralized clinical trials to improve trial access to communities of color;
- Encourage diversity in trial enrollment by exempting free digital health technology that enables trial participation from the Anti-Kickback statute when doing so will facilitate improving clinical trial diversity;
- Allow HHS to issue grants or enter into contractual arrangements to support education, outreach, and recruitment for clinical trials for diseases with disproportionate impact on underrepresented populations;
- 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 or not, such as the ancillary costs of transportation or childcare.
The American Cancer Society Cancer Action Network (ACS-CAN) and Association for Clinical Oncology (ASCO) support the legislation.
“ACS CAN is committed to reducing barriers for patients. The DIVERSE Trials Act will ensure more patients—regardless of their economic means or their geographic location—have a chance to enroll in the best treatment options available without having to bear additional costs or inconveniences,” said Lisa Lacasse, ACS CAN President. “We urge Congress to quickly take up this bill and pass it into law.”