Tuesday | August 24, 2021

Scott, Menendez Introduce DIVERSE Trials Act

Bill would improve clinical trial participation for communities of color

WASHINGTON – U.S. Senators Tim Scott (R-S.C.) and Bob Menendez (D-N.J.) today announced 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 disproportionate impacts on underrepresented populations. Congressmen Larry Bucshon (R-Ind.) and Raul Ruiz (D-Calif.) introduced companion legislation in the House of Representatives.

“One of the many reasons communities of color have historically low vaccination rates is because they are underrepresented in the clinical trials process,” said Senator 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.” 

“For too long, communities of color have been underrepresented in clinical trials,” said Sen. Menendez. “As COVID-19 continues to spread across the country and disproportionately hit densely populated minority communities, it is important that medical professionals and scientists conducting studies on lifesaving drugs and treatments include people of all ethnic and racial backgrounds to ensure they work for everyone. This bill will create more diverse clinical trials and help improve the health of the nation.”

Earlier this year, a report analyzing demographic data from 10 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 that 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 impacts 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 or not to participate in a trial, 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.

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