LSHC Horizons Brochure 2024 - Flipbook - Page 32
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | Clinical Trials
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Decentralized clinical trials in the U.S. and EU
Decentralization of clinical trials is a hot topic
across jurisdictions, both in the pharmaceutical
and in the medical device space. Parts of a
clinical trial may take place outside the setting
of a traditional clinical trial site, ranging
from remote monitoring using digital tools to
delivery of the investigational product to the
patient’s home.
In May 2023, the U.S. FDA released
highly-anticipated draft guidance on the
implementation of DCTs for drugs, biologics,
and medical devices. In the draft guidance,
FDA promotes DCTs as a way to advance
medical product development and to increase
diversity in clinical trial recruitment. There
is a tremendous amount of interest in the
life sciences industry in this policy, as it may
offer substantial benefits to study sponsors.
It, however, also carries potentially significant
regulatory and operational risks, including
how to ensure appropriate oversight of
individuals performing remote trial-related
activities. In finalizing the guidance, FDA will
need to consider the almost 100 comments
to the docket including, for example, the
recommendation that there be a single physical
location where trial records and personnel
reside for inspectional purposes, which seems
in contrast to the definition of DCTs where
all activities take place at sites other than a
traditional clinical trial site. Further, fully
DCTs may not be practical for medical devices
Hein van den Bos
Partner
Amsterdam
that are not intended for self-use or that pose
significant risks to trial participants, but these
may be more appropriately studied in “hybrid
clinical trials” where some activities take place
at a traditional trial site while others take place
at non-traditional sites.
In the EU, both regulators and industry have
expressed interest in decentralized clinical
trials. The European Medicines Agency (EMA),
European Commission, and member state
authorities issued a recommendation paper
on decentralized clinical trials in December
2022. Since then, questions have continued
to arise around, for example, data integrity,
compliance with the General Data Protection
Regulation (GDPR), and the use of data
generated in decentralized clinical trials for
marketing authorization applications. Despite
an EU-wide approach taken by regulators, legal
and practical differences remain on a countryby-country basis. For example, the distribution
of investigational medicinal products direct
to patients’ homes is subject to different
requirements in different countries. When
setting up a cross-border distribution model
for investigational products within the EU,
both EU-level and country-specific regulatory
requirements should be considered.
We expect to see further debate and potential
further harmonization of regulatory guidance
for decentralized clinical trials in the EU.
Kristin Zielinski Duggan
Partner
Washington, D.C.
Bert Lao
Counsel
Los Angeles
