WASHINGTON, D.C. – Last week, U.S. Representatives Brian Fitzpatrick (R-PA), Anna G. Eshoo (D-CA), Chairwoman of the Energy and Commerce Health Subcommittee, and Robin Kelly (D-IL) introduced the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act, legislation aimed at boosting diversity in clinical trials by requiring enhanced data reporting on clinical trial demographics and providing resources to improve access to clinical trials.

“Clinical trials that are representative of all demographics are vital to improving health equity and efficacy for all populations,” said Rep. Fitzpatrick. “I am proud to support the bipartisan DEPICT Act, which will enhance reporting on clinical trial diversity and representation and provide resources to underrepresented communities to improve access and participation in clinical trials.”

“Diverse clinical trials are critical to ensuring that biomedical research is robust and equitable so that all Americans can be confident that the treatments being developed work for patients, regardless of their backgrounds. Unfortunately, clinical trials overwhelmingly fail to achieve a level of diversity reflective of the disproportionate burden of diseases, such as Covid-19, on underrepresented racial and ethnic communities,” said Rep. Eshoo. “The DEPICT Act addresses this lack of diversity by requiring improved reporting standards for clinical trials and boosting resources, such as workshops and community health center grants, to improve access to clinical trials in underrepresented communities.”

“For far too long, the science we rely on for disease treatments, interventions and cures has not been fully researched across racial and ethnic communities. This erodes public trust in the science, researchers, and public health officials,” said Rep. Kelly. “Therefore, I am pleased to co-lead the DEPICT Act with my colleagues Representatives Eshoo and Fitzpatrick. This bill will establish important guidelines for FDA and ensure that Black and Brown communities are represented in clinical trial research so that they have equitable access to state-of-the-art treatment, medications, and medical devices.”

“For too long, racial and ethnic diversity in clinical trials has been, at best, an aspiration and, at worst, an afterthought,” said Dr. Gwen Nichols, Chief Medical Officer at The Leukemia & Lymphoma Society. “The DEPICT Act would empower trusted clinicians in underrepresented communities to help patients participate in clinical trials, while ensuring trial diversity is a priority for the drugmakers sponsoring a trial and the regulators reviewing the results.”   

“Enhancing diversity in clinical trials has been a longstanding and multifaceted challenge,” said Jeff Allen, President & CEO of Friends of Cancer Research. “We applaud Chairwoman Eshoo and Congressman Fitzpatrick for the introduction of the DEPICT Act as it provides new opportunities to improve representativeness and boost confidence in clinical trial results.”

Background

Enhancing data reporting on clinical trial demographics

The DEPICT Act:

• Requires Investigational New Drug (IND) and Investigational Device Exemption (IDE) applicants to:
  • Report clinical trial enrollment targets by demographic subgroup, including age, race, ethnicity, and sex, and provide a rationale for those targets.
  • Provide a Diversity Action Plan detailing the actions the sponsor will take, such as outreach and engagement strategies, to reach these enrollment targets.
• Provides FDA with the authority to mandate post-market studies when sponsors fail to meet diversity enrollment targets and do not provide a sufficient justification.
• Requires FDA to publish an annual report aggregating and analyzing the data provided by sponsors on their progress toward and strategies for improving diversity in clinical trials.

Resources for communities to improve access to clinical trials

The DEPICT Act:

• Requires FDA to hold a workshop to assess how sponsors utilized the clinical trial flexibilities initiated during the COVID-19 public health emergency and their impact on improving access to clinical trials in underserved populations.
• Provides funding to NIH for community engagement & outreach efforts to increase inclusion of underrepresented minorities in clinical trials and research.
• Provides grant funding to Community Health Centers to increase their capacity to participate in clinical trials and research.

The bill text for the DEPICT Act can be found here.

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