The Depict Act
Passed by Congress in December of 2022, the Diverse and Equitable Participants in Clinical Trials (DEPICT) Act is targeted at applicants who request exemptions from the Food and Drug Administration (FDA) for a new drug of medical device to include information about the demographic diversity of the clinical trial and other pertinent information. The act requires exemption applicants to include certain information, including:
- Demographic data disaggregated by subgroup, where such data is available, about the expected or potential patient population;
- The applicant’s enrollment targets for the clinical trials involved, disaggregated by age group, sex, race, and ethnicity;A diversity plan for how the applicant will meet these targets; and
- Comorbidities, which is considered patient population information.
The Illinois Diversity in Clinical Trials Act
Sponsored by Illinois State Senator Julie Morrison and Representative Marcus Evans, the Diversity in Clinical Trials Act was signed into law on August 9, 2024 by Governor JB Pritzker and becomes effective on January 1, 2025. It seeks to improve diversity and reduce barriers to participation in clinical trials in Illinois.
It requires any state entity or hospital that received funding from the National Institute of Health for the purpose of conducting drug or medical device clinical trials to adopt a policy that will result in the identification and recruitment of persons who are members of underrepresented demographic groups to participate in the clinical trials and that it must include specific strategies for trial enrollment and retention of diverse participants, including, but not limited to, site location and access, sustained community engagement, and reducing burdens due to trial design or conduct, as appropriate.
In addition to using strategies recommended by the United States Food and Drug Administration to identify and recruit those persons to participate in the clinical trials, the entity of hospital must provide:
-
- Information to trial participants in languages other than English in accordance with current federal requirements;
- Translation services or bilingual staff for trial recruitment and consent processes;
- Culturally specific recruitment materials alongside general enrollment materials; and
- Remote consent options when not prohibited by the granting entity or federal regulations.
It also requires the Illinois Department of Public Health to receive through voluntary reporting from research institutions and in consultation with community-based organizations and other stakeholders as appropriate and available, shall analyze and provide recommendations on:
-
- The demographic groups and populations that are currently represented and underrepresented in clinical trials in Illinois, including representation of groups based on their geographic location;
- The barriers that prevent persons who are members of underrepresented demographic groups from participating in clinical trials in Illinois, including barriers related to transportation; and
- Approaches for how clinical trials can successfully partner with community-based organizations and others to provide outreach to underrepresented communities.
