Healthcare organizations advocated to improve diversity among clinical trials in a letter sent to U.S. Congress in May encouraging the government to take steps as the reauthorization of the Prescription Drug User Fee Act (PDUFA) approaches. The PDUFA allows the U.S. Food and Drug Administration to review and approve drugs, but the authorization is set to expire in September of 2022.

The healthcare organizations asked Congress to promote inclusion and strengthen diversity in clinical trials by:

  • Require clinical trial sponsors to build measurable enrollment targets into their trials
  • Allow for certain trial services to be provided in a patient’s home or community health facility
  • Invest in community-based providers to improve outreach to underrepresented populations
  • Allow clinical trial sponsors to provide financial assistance to patients  

“Although most patients with cancer express a willingness to participate in clinical research, only a small fraction ultimately end up enrolling in a cancer clinical trial due to barriers that make participation difficult or even impossible.” Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said. “This provision would benefit both patients and research by improving access to lifesaving clinical trials, ensuring that trial participants are more socioeconomically, geographically, and racially diverse, and accelerating the development of new and better treatment options for patients.”

“Greater diversity in clinical trials is a true ‘win-win,’” Katie Berge, director of federal affairs for the Leukemia and Lymphoma Society, said. “It means more individuals will have access to the latest treatments. And it means the data underpinning medical innovation will be better and more reliable. Millions may benefit from these reforms.”

ONS was one of 89 organizations that signed the letter to Congress in the Society’s ongoing support for improved access to care. Without essential services that reduce the risk, morbidity, and mortality of cancer, people across all populations can suffer. All people should have access to equitable, comprehensive, affordable health care, especially those in underserved communities.