February 2024 SOCRA Source Journal - Journal - Page 55
chemotherapy. Frequent inperson chemotherapy treatment
was also a big part of the phase
III trial looking into the “efficacy
and safety study of ABP 980
compared with trastuzumab in
women with HER2-positive early
breast cancer” and the phase
II trial examining “biweekly
gemcitabine, paclitaxel,
and Avastin in patients with
metastatic breast cancer,” which
also had lower participation
among AAs than whites.
The Current State of AA
Participation in Clinical Trials
During COVID-19
Due to the SARS-CoV-2 virus’s
highly contagious nature,
clinical trials were required
to implement necessary
procedures to restrict the
spread of the disease. Trial
protocols were revised to
conform to the new FDA and
NCI guidelines in response
to the pandemic, and the
adjustments targeted the
two factors AAs have against
participating in clinical trials.
The main adjustment leading
to the post-COVID-19 roadmap
to clinical trials is decentralizing
clinical trial sites using
technology for participants’
remote participation.
Both the FDA and NCI provided
guidance for clinical trials to
perform remotely informed
consenting through telephones
or video conferences.17,18
To account for COVID-19related travel limitations and to
prevent any potential spread
of the virus outside of the
home, the changed guidelines
are now implemented in
conjunction with technology
that offers participants the
opportunity to hear and see
the investigators organizing
the clinical trials at home. The
FDA guidance recommends
both the participant and the
investigator review the informed
consent form together, the
investigator answer any
questions the participant might
have throughout, and requires
both verbal confirmation and
a signature, either handwritten
or digitally, as long as the
electronic signature follows the
rules laid out under 21 CFR 11.17
Although the NCI guidance
does not specify information
about electronic signatures,
the same process of going
over the consent form virtually
at the participant’s house is
supported.18 By facilitating the
engagement of investigators,
improving the understanding
of a trial visually and auditorily,
and saving time and cost for
participants having to come
to the trial site, the remote
informed consent process
builds more credibility among
the participants toward clinical
trials, targeting both AAs’
mistrust and socioeconomic
factors. It allows for the
participant to interact within
their own space, where they
may be more comfortable than
in an institutionalized medical
setting. In an observational
study comparing the effects of
video-based informed consent
against text-based informed
consent in the Patient and
Provider Assessment of Lipid
Management (PALM) study
conducted in 2015, not only
did a greater proportion of AA
participants participate than
in other recent cardiovascular
clinical trials, but also a higher
percentage of AAs approved
of the video consent capability
in which the traditional text-
based informed consent is
divided into 6 video vignettes
totaling 8 minutes.53 Once
the videos were downloaded,
participants could proceed
with the informed consent
process without an internet
connection, and the videos
gave a comprehensive overview
of the PALM study rationale
and duration, risks and benefits,
costs, and confidentiality
involved with participating.53
Participants could set a flag
anytime they encountered a
topic or concept with questions,
and the study investigator
was required to clear the flags
after answering participants’
questions.53 At the end of the
6 videos, both participants and
the investigators had to sign the
electronic consent form using
either their fingers or the tablet
pencil.53 Unlike The Tuskegee
Study of Untreated Syphilis in
the Negro Male, where AAs
were not informed about the
trial and were mistreated,
remote informed consenting
permits participants including
AAs to fully grasp the purpose
of the clinical trial in a setting
where they are comfortable,
to voluntarily give approval to
participate in the trial without
force, and to directly talk to
the investigators about the
trial face-to-face, hence rebuilding AAs’ trust toward
clinical trials and improving trial
participation.
Another common feature
shared between the FDA and
NCI’s adjusted guidelines
is enabling nearby local
healthcare providers to
complete certain research
tasks on behalf of the enrolling
study sites to accommodate
for travel restrictions and
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