LSHC Horizons Brochure 2024 - Flipbook - Page 35
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | Clinical Trials
Forecasting FDA activities to foster diversity in clinical research
The U.S. Congress, FDA, and industry have
taken several bold steps to increase the
enrollment of historically underrepresented
populations in clinical research in recent years.
Looking ahead, we anticipate how FDA will
continue to emphasize and set expectations
regarding diversity in clinical trials and explore
the potential directions that industry may take
in fostering diversity in clinical research.
In the Food & Drug Omnibus Reform Act of
2022 (FDORA), Congress directed FDA to
require that sponsors submit diversity action
plans describing the sponsor’s (1) enrollment
goals disaggregated by race, ethnicity, sex,
and age, (2) rationale for the goals, and (3)
an explanation of how the sponsor intends to
meet the goals. This requirement will apply to
all Phase 3 clinical trials conducted for drugs
and biologics, as well as for all devices and
diagnostics that use the 510(k), premarket
approval, de novo, and investigational device
exemption pathways, with some exceptions.
FDORA also mandates that FDA publish
draft guidance documents on how FDA
plans to implement the diversity action plan
requirement. Such guidance is likely to feature
recommendations on the content of a diversity
action plan, including circumstances under
which a diversity plan waiver may be granted.
Although the statutory deadline for issuing the
diversity action plan guidance was December
2023, FDA has yet to publish the guidance. We
anticipate that the agency will likely issue it
early this year.
Stephanie Agu
Senior Associate
Miami
FDA is likely to continue encouraging greater
collaboration between sponsors and the
communities where clinical trials are conducted
and emphasize transparency in reporting and
analyzing demographic data. In early phase
discussions with the agency, sponsors should be
prepared to field questions on their relationships
to diverse patient communities, including
education and recruitment strategies aimed at
underrepresented patient groups. This year may
also see FDA provide detailed recommendations
on how sponsors should collect, analyze, and
report demographic information, and conduct
sound subgroup analyses.
Embracing diversity in clinical trials is a
crucial step towards ensuring that scientific
findings are applicable and beneficial to all
members for the relevant patient population.
As FDA continues to evolve its approach
to clinical trial oversight, sponsors should
proactively incorporate diversity into their trial
designs and recruitment strategies, working
collaboratively with communities and health
care providers to achieve more inclusive and
representative clinical research outcomes.
Deborah Cho
Senior Associate
Washington, D.C.
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