November 2024 SOCRA Source Journal - Journal - Page 68
Background/Aims: As part of
the National Institutes of Health’s
Helping to End Addiction
Long-Term (HEAL) Initiative, an
ongoing body of research has
been underway with a primary
goal of addressing neonatal
opioid withdrawal syndrome.
Speci昀椀cally, the Advancing
Clinical Trials in Neonatal Opioid
Withdrawal Syndrome (ACT
NOW) research initiative aims to
inform the clinical care of infants
exposed to opioids during
gestation. The ACT NOW clinical
trials endeavored to focus on
the comparative effectiveness
of different medication
strategies in the treatment of
NOWS as well as evaluation
of comprehensive care quality
improvement strategies that
include pharmacologic and
nonpharmacologic approaches
(such as Eat, Sleep, and Console)
in combination with an array
of advanced approaches to
identifying babies suffering from
NOWS.1 ACT NOW trials have
been conducted at multiple sites
across the United States, with
study implementation occurring
amid the unprecedented
coronavirus (SARS-CoV-2) and
resulting coronavirus disease
2019 (COVID-19) pandemic.
The pandemic resulted in farreaching disruptions with respect
to all aspects of clinical care
throughout the United States
and around the globe. The
clinical research realm was no
exception with the pandemic
presenting numerous challenges
to performing clinical research,
among them enrollment and
protocol adherence challenges
because of decreased patient
visits, staf昀椀ng restrictions
and limitations, and limited
availability of ancillary services.2
As the pandemic brought
68
sweeping changes to the
landscape of clinical trial
conduct, both the U.S. Food
and Drug Administration (FDA)
and the European Medicines
Agency issued timely guidance
to aid researchers in maintaining
good clinical practice standards
and patient protection while
still allowing for continued trial
execution.3 This guidance was
essential given the urgency for
revisiting the feasibility and
effectiveness of remote clinical
monitoring given that travel
restrictions, quarantines, and
other public health safety–related
concerns led to the prevention of
traditional onsite monitoring at
most research sites.4
The concept of remote
clinical site monitoring is not
new. In FDA’s 2013 guidance
document, Oversight of Clinical
Investigations – a Risk-Based
Approach to Monitoring, the
agency noted that centralized
monitoring techniques could
be employed to “supplement
or reduce the frequency and
extent of on-site monitoring with
monitoring activities that can be
done as well or better remotely
or with monitoring activities
that can be accomplished using
centralized processes only.”5
The advent of technology such
as video-conferencing platforms,
enhanced data capture systems,
and electronic trial master 昀椀les
has allowed for the clinical
trials enterprise to venture
increasingly into an operational
model that includes more
remote components.3 One of the
most important technological
advancements in recent years is
the expanded (nearly ubiquitous)
use of the electronic medical
record (EMR) or electronic health
SOCRA SOURCE © November 2024
record (EHR), which, in theory,
permits clinical monitors to
perform veri昀椀cation of source
data and documentation
remotely.6 According to
www.HealthIT.gov, as of 2021,
88% of U.S. of昀椀ce-based
physicians had adopted the EHR.
The experience of the
COVID-19 pandemic, however,
resulted in a sudden, urgent,
and increased demand for
processes and procedures
for conducting clinical trials
research remotely.3 Given the
lack of in-depth experience
with the remote execution
and oversight of clinical trials,
the pandemic illuminated the
need for a comprehensive
approach and clear set of
guidelines addressing remote
clinical research (including
remote clinical monitoring)
while preserving trial integrity
and upholding regulatory
requirements. Rising to this
challenge, the ACT NOW study
leadership team made a quick
pivot to move from traditional
onsite monitoring to fully
remote/virtual site monitoring
with a goal of ensuring that site
monitoring activities could occur
at the same frequency and with
the requisite focus on quality
and data integrity as speci昀椀ed in
the study protocol and manual.
Despite the lack of an existing,
well-established remote site
monitoring precedent upon
which to build, the ACT NOW
leadership team worked to
preemptively structure robust
remote site monitoring processes
and procedures for two national,
multisite trials. This effort
revealed several best practices
and valuable lessons learned,
with broad implications in the
realm of clinical trials monitoring
