The CAP has joined with 71 other organizations representing patients with chronic and acute health conditions to urge the Senate to take up critical provisions in the House Prescription Drug User Fee Act (PDUFA) reauthorization, which, if implemented, would improve diversity in clinical trials.

In a June 8 letter to ranking members on the Senate Committee on Health, Education, Labor & Pensions, the groups note that most clinical trials fail overwhelmingly to achieve diverse enrollment, even though many serious and chronic diseases disproportionately impact underrepresented racial and ethnic minority groups.

“This lack of diversity in trial enrollment inhibits a full understanding of how safe and effective new drugs might be across their intended populations,” they write. “It also exacerbates disparities in access to treatment when enrolling in a clinical trial may be a patient’s most effective treatment option.”

The groups note that the House has already advanced a legislative package that makes real and meaningful reforms to help ensure patients in every part of the country have access to the clinical trial care they need. They are calling on the Senate to address the following as part of the PDUFA reauthorization:

• Premarket reporting of diversity action plans to ensure enrollment of diverse populations.
• Evaluation of the need for additional post-market activities if trial sponsors fail to meet enrollment or diversity targets.
• Decentralized clinical trials and COVID-19 trial flexibilities that would allow certain trial services to be provided at community provider facilities.
• Public workshops to enhance clinical trial diversity by soliciting input from sponsors, manufacturers, patients, providers, and other stakeholders.
• Annual progress reporting by the Food and Drug Administration on how barriers to increasing diversity in clinical trials are being addressed.
• Improve outreach to underserved patients and providers by allocating federal resources for community health center grant programs that support hiring and training culturally competent onsite personnel to conduct and recruit for clinical trials.
• Minimize financial barriers to getting to a clinical trial location by ensuring federal rules allow sponsors to provide financial assistance to trial enrollees without the threat of liability.

“As America becomes more racially and ethnically diverse, a clinical trial system that fails to enroll patients from growing demographics will not support the pace of innovation that will help us meet the needs of patients with chronic and acute health needs,” the groups say in their letter. “We urge you to take real and meaningful steps towards this future by incorporating the critically important policies included in Title V of the House PDUFA reauthorization bill.”