LSHC Horizons Brochure 2024 - Flipbook - Page 31
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | Clinical Trials
Decentralization and digitalization trends in European clinical trials:
A focus on data aspects
Decentralized clinical trials (DCTs) are
reshaping the landscape of medical research
in Europe, integrating digital technologies
to enhance participant involvement beyond
traditional clinical settings. This innovative
model offers significant benefits such as
increased accessibility, cost reductions, and
the potential for more diverse patient groups.
It, however, introduces unique legal and
regulatory challenges, particularly in terms of
data protection and participant privacy.
The integration of digital tools in DCTs, like
eConsent and tele-visits, significantly improves
participant access and engagement. Yet, these
advancements also raise substantial concerns
pertaining to the General Data Protection
Regulation (GDPR), data transfers outside
Europe, and the safeguarding of participant
privacy. Ensuring GDPR compliance is essential,
particularly when handling sensitive health
data, vital for validating trial outcomes, and
supporting marketing authorization processes.
A major aspect of GDPR compliance in the
context of DCTs involves the careful management
of health data and its separation from direct
identifiers, a principle well-established in
clinical research for years. Traditionally, trial
sponsors must not collect the names of the
patients. This practice is key for protecting
participant confidentiality while adhering to
GDPR provisions. Thus, the implementation of
eConsent in DCTs requires meticulous attention
to ensure privacy, and informed, voluntary,
transparent participant consents.
Patrice Navarro
Partner
Paris
These developments signify a historical shift in
clinical trial practices.
Taking this into account, the European
Commission released its recommendations
on DCTs in December 2022 to underscore the
importance of digital tools and decentralized
procedures in health research. Many countries
and authorities, following the European
Commission's recommendations, are actively
working to adapt and implement these new
practices. An innovative EU pilot project
has been launched to align innovation with
GDPR compliance. In France, like in several
European nations, there has been a request
for involvement in the pilot phase (until June
2024) and it is expected that guidelines will be
released between 2024 and 2025, which will
reflect these developing practices.
In conclusion, the EU’s initiatives in
decentralized clinical trials are poised to
significantly advance medical research, while
simultaneously addressing the complexities
of GDPR compliance. It is hoped and believed
that the upcoming guidelines will introduce
flexibility in this area, enhancing the efficiency
of clinical trials while rigorously safeguarding
patient privacy rights. This delicate balance
between technological innovation and legalethical considerations is crucial in shaping the
future of clinical trials in the EU, promising a
more dynamic, effective, and ethically robust
research environment.
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