2021 LS&HC Horizons - Flipbook - Page 16
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Clinical Trials
Hogan Lovells
The U.S. clinical trials landscape
The COVID-19 pandemic created unprecedented
difficulties for the regulation and operation of clinical
trials. These challenges include issues with travel
restrictions, remote visits and monitoring, informed
consent, supply chains, and more. Regulators
responded with guidance acknowledging the impact
of COVID-19 and provided greater regulatory
flexibility in meeting protocol and Good Clinical
Practice (GCP) requirements. As we look to a postCOVID world, the question is which of these changes
will stick. Moreover, the recent focus on diversity has
also impacted clinical trials, and this prioritization
is likely to increase under the Biden Administration.
Below, we focus on COVID-19 related changes that we
believe could be permanent and analyze why.
Telehealth participation, remote informed
consent, remote monitoring, and home delivery
of investigational product
In a FDA guidance that has been updated repeatedly
since March 2020, the agency has issued an evolving
set of recommendations to address COVID-19-related
challenges including:
• Managing protocol deviations that are related
to the pandemic,
• Performing outcome assessments remotely,
• Proper administration of investigational drugs,
• Addressing supply chain disruptions,
• Home delivery and administration of
study drugs,
• Using alternative facilities,
• Video conferencing for trial visits, and
• Conducting remote monitoring.
In the guidance, FDA indicated it will permit a
substantial amount of flexibility to sponsors and
investigators to protect the safety of subjects and the
integrity of ongoing trials. For example, the guidance
states: “Changes in protocol conduct necessary to
immediately assure patient safety, such as conducting
telephone or video contact visits for safety monitoring
rather than on-site visits, can be immediately
implemented with subsequent review by the IRB and
notification to FDA.”
We anticipate that this regulatory flexibility is
likely to continue after the pandemic ends. Ex-FDA
Commissioner Stephen Hahn has said that remote
monitors and telehealth check-ins made necessary by
COVID-19 may become permanent fixtures of clinical
trials. We agree that after industry and regulators
have seen benefits from the significant efforts made to
streamline and maintain high quality remote care and
patient satisfaction with on-line tools, these aspects of
clinical trials could remain remote.
The guidance also promotes new methods for
obtaining informed consent from hospitalized
patients in isolation. FDA provides guidance on how
to obtain informed consent from prospective trial
participants in circumstances where the enrollment
timeframe is limited and the patient can receive an
informed consent form electronically. For example,
the guidance cites the COVID-19 MyStudies App
as an option for electronic informed consent when
face-to-face contact is not possible. This trend is
bolstered by the tremendous interest in digital tools
to connect patients with their doctors and clinical
trial sites. And, the cost savings might mean this can
continue, particularly for trials that can be conducted
in outpatient settings.
Despite the progress in FDA’s thinking about
flexibility in clinical trials, significant questions
remain about how sponsors and investigators will
successfully implement these new approaches.
For example:
• Will hospitals permit drug and device
companies to access the hospitals’ electronic
medical records to facilitate remote monitoring
and source data verification?
• What will FDA’s long-term expectations be for
new technologies that were first used during
the pandemic (e.g. to facilitate remote patient
