On February 3, 2022, Rep. Anna G. Eshoo (D-CA), Chairwoman of the Energy and Commerce Health Subcommittee, Rep. Brian Fitzpatrick (R-PA), and Rep. Robin Kelly (D-IL) introduced the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act, a bill to strengthen diversity in clinical trials. This legislation aims to increase diversity in clinical trials by requiring enhanced data reporting on clinical trial participant demographics and provide resources to underrepresented communities to improve access and participation in clinical trials.
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. Additionally, applicants will need to provide a Diversity Action Plan detailing the actions the sponsor will take, such as outreach and engagement strategies, to reach these enrollment targets. Diversity Action Plans may include demographic-specific outreach and enrollment strategies, study-site selection, clinical trial inclusion and exclusion practices, and any diversity training for trial personnel.
This act will also provide FDA with the authority to mandate post-market studies when sponsors fail to meet diversity enrollment targets and do not provide a sufficient justification.
The FDA will be required 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.
Workshops will be held by the FDA to assess how sponsors utilized the clinical trial flexibilities started during the COVID-19 public health emergency and their impact on improving access to clinical trials in underserved populations.
As part of this act, NIH will receive funding for community engagement and outreach efforts to increase inclusion of underrepresented minorities in clinical trials and research. It will also supply grant funding to Community Health Centers to increase their ability to participate in clinical trials and research.
The bill text for the DEPICT Act can be found here.
The need to increase diverse patient participation in clinical trials has been a critical industry-wide need for many years. Requests from sponsors and CROs are already increasing for sites with diverse enrollment experience. SCRS highly encourages research sites to participate in the Diversity Site Assessment Tool (DSAT), a first-of-its-kind assessment to help sites understand their knowledge in recruiting and meeting the needs of diverse patient populations in clinical trials. Based on legislation such as the DEPICT Act, sites that have more experience in this key area may receive preference from sponsors and CROs.
It is imperative to continue collaborative discussions between industry, sites, and regulators to address how to take action to ensure diverse representation in clinical trials. At the Diversity Site Solutions Summit, industry leaders will come together to share innovative best practices for engaging diverse populations as regulatory and sponsor directives require more inclusion in trials. SCRS encourages sites and industry to attend and share their input through solution-focused discussions at the Summit.
The SCRS Talks podcast discusses the DEPICT Act further below