February 11, 2022
US Congress Members Introduce Bill to Boost Diversity in Clinical Trials
In the United States, legislation to increase diversity in clinical trials by requiring enhanced data reporting of participant demographics, has been introduced by three members of Congress.
The bipartisan Diverse and Equitable Participation in Clinical Trials (DEPICT) Act was introduced last week by Congress members Anna G. Eshoo - Chairwoman of the Energy and Commerce Health Subcommittee, Brian Fitzpatrick, and Robin Kelly. The legislation requires improved reporting standards and increased resources, such as workshops and community health center grants to encourage more diverse participation and improve access to clinical trials.
The Act comes at a time when the issue of disparities in healthcare is under the spotlight due to the pandemic. The goal is to increase trust in public health by ensuring treatments, interventions and cures are fully researched across racial and ethnic groups.
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.
Key points in the Act include:
- Investigational New Drug (IND) and Investigational Device Exemption (IDE) applicants will be required to report clinical trial enrollment targets by subgroups such as race, ethnicity and sex and provide rationale for those targets.
- The Food and Drug Administration (FDA) will have the authority to mandate post-market studies when sponsors do not meet diversity enrollment targets without good reason.
- The FDA will publish an annual report aggregating and analyzing data provided by sponsors on progress towards goals for increasing diversity in clinical trials.
The Act has won plaudits from public health organizations and charities for providing new opportunities to increase diverse representation, which improves the ability to gain knowledge about the safety and efficacy of potential drugs.
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.
Dr. Gwen Nichols
Chief Medical Officer at The Leukemia & Lymphoma Society
Other information about the DEPICT Act:
- The Act requires the FDA to hold a workshop to assess how sponsors utilized the clinical trial flexibilities introduced during COVID-19 and their impact on access to clinical trials in underserved populations.
- Funding is provided to the National Institutes of Health (NIH) to increase inclusion of underserved minorities in clinical trials and research.
- Grant funding is provided to Community Health Centers for community engagement, outreach efforts and to increase participation capacity in clinical trials and research.