February 2024 SOCRA Source Journal - Journal - Page 52
of trust in the AA community.
Due to the gross misconduct
and breaches of study ethics,
AA participants became far less
likely to participate in clinical
trials, and AA physicians were
also less likely to recommend
clinical trials for their AA
participants.28,29 While trust
was a factor unique to AAs,
income was a common barrier
for both AAs and whites, and
health literacy and geographic
location were shared barriers
for AAs, whites, and Latinos/
Hispanics. In comparison to
whites specifically, at lowincome levels, participation was
reduced for both. However,
as income levels rose, white
participation increased at a
much higher rate than that of
AAs. This data suggests that
increasing income alone is not
enough to bridge the gap in
participation and reinforces that
the lower rates of participation
are experienced by AAs even at
higher income levels.
The updated FDA and NCI
guidelines target the issues
of trust and socioeconomic
barriers with decentralized
trial methods. Three out of
54 articles recommended
the usage of an electronic
informed consent form, and 7
out of 54 articles recommended
adopting telemedicine for
remote monitoring and drug
administration. Additionally,
4 articles provided evidence
of telemedicine increasing
the representation of AAs
following the implementation
of COVID-19 protocol
amendments. Out of 40
completed oncology clinical
trials during both pre-and
post-pandemic obtained from
clinicaltrials.gov, 10 clinical
52
trials conducted between 2000
and 2019 portrayed similar
representation percentage
gaps between whites and
AAs according to the data
reported by the US census
Bureau, and 3 clinical trials
conducted between 2019 and
2022 showed an increased
enrollment among AAs.
With the help of technology,
participants can build trust
with trial investigators through
a face-to-face video call, and
participants are no longer
required to go to a clinical trial
site to receive investigational
drugs as they can be shipped
and monitored through webbased tools.30,17 Although
more data is needed on the
measurable impact of FDA
and NCI guidelines amended
due to the pandemic on AA
participation in clinical trials,
the results of race distributions
once the ongoing clinical trials
have been completed will be a
critical measure of the potential
for future inclusion efforts.
DISCUSSION
Two Major Barriers
Contributing to African
American Underrepresentation
in Clinical Trials
The inconsistency between
AA enrollment in oncology
clinical trials and the substantial
prevalence of cancer among
AA is alarming. The lack of
efficacy and safety data for
oncology products in the
AA population represents a
significant challenge for labeling
indications and accurate
prescribing in AA patients.
Moreover, AAs will continue to
remain at higher risk for cancer
deaths without improvements
to standards of care, which
often rely on data from clinical
SOCRA SOURCE © May 2023
trials. Recognizing the disparity
in trial participation, doctors
investigated certain factors
that may have played a role
in lowering the representation
of AAs in clinical trials as part
of their efforts to alleviate
healthcare inequities. Involving
physicians from the National
Medical Association (NMA), an
organization that represents
AA physicians, the Eastern
Cooperative Oncology Group
investigated the barriers that
impede participants from
engaging in oncology clinical
trials.18 NMA physicians
have expressed substantial
reservations about clinical trial
venues due to the Tuskegee
incident.18 The Tuskegee
Study of Untreated Syphilis
in the Negro Male was a US
Public Health Service (PHS)
observational study of AA males
in Tuskegee, Alabama (1932–
1972). Even after the discovery
of penicillin, the PHS watched
399 syphilitic participants’
disease progressions and
conducted autopsies on dead
bodies without alerting the
participants of the nature of
their disease or treating them
with penicillin.28,29 The events
that occurred during this
investigation were spurred by
the growth of eugenics and
racism, as well as the US Army’s
past medical experiments
in colonies and abroad.28,29
AAs’ mistrust of research
can be extrapolated from
incidents like the Tuskegee
study that lacked transparency
and communication, causing
participants to feel exploited,
abused, and subjected to
consequences of “involuntary
admissions, side effects,
or stigmatization.”28,29 This
perception among the AA