Life Sciences Horizons Brochure 2025 - Flipbook - Page 48
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2025 Horizons Life Sciences and Health Care
U.S. clinical trial diversity recommendations under review
In June 2024, FDA released its draft guidance on
Diversity Action Plans (DAPs) for clinical trials, titled
“Diversity Action Plans to Improve Enrollment of
Participants from Underrepresented Populations in
Clinical Studies.”
This guidance was mandated by the Food and Drug Omnibus
Reform Act of 2022 (FDORA), which established a new framework
to promote clinical trial diversity. Under FDORA, certain drug and
device sponsors are required to submit DAPs for pivotal trials
demonstrating the sponsor’s goals for enrolling representative
numbers of participants from historically underrepresented
populations in clinical trials, the rationale for the goals, and the
strategy to achieve the goals. FDA’s June 2024 draft guidance
provides recommendations to sponsors on developing DAPs,
including by offering insights on waiver criteria, DAP submission
timelines, potential postmarketing requirements, applicability of
DAPs to multinational studies, and the use of real-world evidence
to estimate disease prevalence in different demographic groups.
The DAP requirement is scheduled to become effective 180 days
after FDA finalizes the guidance. However, since taking office,
President Donald Trump has shown strong opposition towards
diversityrelated activities that were commonplace in recent years.
President Trump has terminated the federal government’s
diversity, equity, and inclusion (DEI) activities and directed the
Department of Justice to closely scrutinize related activities of
private companies. With this in mind, it appears likely that the
Trump administration will delay finalizing or choose not to
finalize the DAP guidance. If the Trump administration moves
forward with finalizing the DAP guidance, the final version may
bear little resemblance to what is currently in effect.
Regardless of whether DAPs are required and enforced,
enrollment of appropriate demographic subgroups in clinical
trials has been a longstanding priority for FDA and is rooted in the
critical tenet that clinical trial data must support safe and effective
use of the product in the intended patient population. This
priority has been reflected in other guidance documents
addressing diversity in clinical trials, including guidance on
collecting and reporting race and ethnicity data, and
recommendations for sexspecific analyses. Because the collection
and reporting of demographic data to ensure clinical trials are
appropriately representative informs the safety and efficacy of
medical products, sponsors should review their efforts in this
space to confirm that their studies will meet all statutory and
regulatory requirements. We expect that diversity in clinical
trials will remain a closely-watched topic in 2025.
Deborah Cho
Counsel
Washington, D.C.
Stephanie Agu
Senior Associate
Miami
Ashley Grey
Associate
Washington, D.C.
