February 2024 SOCRA Source Journal - Journal - Page 57
populations, and their recent
COVACTA and EMPACTA
trials are implementing the
new approach.60 Moreover, the
FDA made an announcement
on April 13, 2022, to require
pharmaceutical companies to
submit a Race and Ethnicity
Diversity Plan to the FDA in
the early clinical development
process to ensure enrollment
of more underrepresented US
populations in clinical trials.61
Although whether this new
change brought an increase
in AA participation cannot be
confirmed as it takes time for
participants to be enrolled and
clinical trials to be completed,
pharmaceutical companies now
have to take AA participation
and its expansion into
consideration per FDA’s request.
Case Study: VA-LCSDecTool
One specific example of an
ongoing clinical trial that is
carrying out the FDA and NCI
recommendations in response
to SARS-CoV-2 and gaining
more AA representation is
the VA-LCSDecTool multi-site
clinical trial conducted by the
Veterans Affairs Health Care
System. With the intervention
to evaluate the impact of
a web-based Lung Cancer
Screening Decision Tool
(LCSDecTool) on traditional
oncology care, the trial’s goal
for participant population
recruitment is distributed as
40% of AAs, 5% of Hispanics,
and 10% of women.62 Although
the trial initially required inperson primary care visits, the
COVID-19 pandemic has forced
the trial to adopt protocol
revisions to utilize telemedicine.
In addition to editing the
LCSDecTool design so that it
can be implemented on devices
used for telemedicine such
as tablets, smartphones, and
computers, the trial enabled
the tool to be accessed through
a URL .63 For participants who
lack computer literacy and
knowledge, this user-friendly
feature was also put into the
tool design.63 For participants
who live in an area with low WiFi, the tool only needs to be
accessed on the participants’
first visit so that they do not
have to worry about accessing
the internet throughout the
entire trial duration.63 These
modifications made it easier
for participants who live in
rural areas or couldn’t get to
the hospital on a regular basis
to participate in the research
study through the usage of
a digital platform, and this is
highly beneficial to AAs who are
densely located in the South
where fewer clinical trial sites
are located.19
CONCLUSION
The FDA and the NCI
guidelines have overlapping
changes regarding the clinical
trial protocols impacted by
the SARS-CoV-2 outbreak,
and these changes have the
potential to increase African
American enrollment in clinical
trials, especially in oncology.
The first main change to
implement remote informed
consenting may restore AAs’
lost trust from the Tuskegee
Study of Untreated Syphilis
in the Negro Male toward
clinical trials and investigators.
The second main change to
decentralize clinical trials to
enable the administration of
investigational drugs at home
or at local sites may remove the
economic burden from AAs.
Many clinical trials are going
through the process of adjusting
to the guidelines, as seen by
the LCSDecTool example, and
at least 3 large pharmaceutical
companies are already following
the updated guidelines. There
is no definite published data
on whether the changes have
increased AA recruitment and
enrollment due to the long
duration of each clinical trial
phase.64 However, regulatory
authorities and pharmaceutical
companies have high hopes that
the changes will bring positive
outcomes more favorable to
AAs in eventually decreasing
their cancer death rates and
providing real-life efficacy data
from oncology investigational
drugs. In consideration for
future research, it will be
crucial to analyze data on the
effects of AA participation in
oncology clinical trials with the
implementation of decentralized
clinical trial methods,
including electronic informed
consent, recruitment of AAs
in their communities, and
telemedicine. It is imperative
that clinical trial sponsors and
sites continually examine the
effects of trial procedures
on participant diversity and
take action to implement
innovative methodologies to
ensure results. Realizing the
goal of inclusive representation
in clinical trials will take a
concerted effort among all
stakeholders to consistently
reach out to underrepresented
populations and address
systemic issues that have
historically skewed clinical trial
data on the basis of race.
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