February 2024 SOCRA Source Journal - Journal - Page 54
According to the JAMA article,
“Geographic Accessibility to
Clinical Trials for Advanced
Cancer in the United States,”
45.6% of metastatic breast
cancer participants, 50.2% of
prostate cancer participants,
52.2% of colorectal cancer
participants, and 38.4% of nonsmall lung cancer participants
had to drive more than 60
minutes one way to access
the nearest clinical trial site.39
Moreover, South Central is
noted as the region to have the
longest travel time, more than 1
hour.39 This forces a participant
to contribute at least 2 hours
of their time and potentially
pay transportation expenses,
including gas, and bus/car fare
for every single on-site study
visit. While some clinical trial
sponsors may reimburse certain
study-related costs, there is
still a large participant burden
associated with extended
travel requirements. Large
distance from clinical sites
disproportionately impacts
AA participants. In a study
assessing geographic proximity
and racial disparities in cancer
clinical trial participation, AAs
were compared to whites
living within Baltimore City.
Even with the same relative
distances from clinical sites, AA
had significantly less clinical
trial participation compared to
whites (10.9% vs. 85.4%).24,40
During the COVID-19
pandemic, larger travel times
also exposed participants who
are often immunosuppressed to
a much larger risk of exposure
and infection. Not only do
participants spend at least
120 minutes driving, but they
also must pay for the gas used
during that journey. Multiple
articles investigated South
54
Carolina as the target location
where numerous AAs reside to
improve clinical trial perceptions
among the AA population.
Within South Carolina,
Williamsburg is the area with
the densest AA population, but
there are no clinical trial sites
registered or actively recruiting
in Williamsburg County.41,42
These barriers are depicted in
the percentage gap between
AAs’ and whites’ participation
in the 10 oncology clinical trials
screened from the systematic
review 43,44,45,46,47,48,49,50,51,52
A phase II trial evaluating
“fulvestrant plus enzalutamide
in ER+/Her2- advanced
breast cancer” had a total of
84.4% white and 9.4% AA
participation.43 Because of
the chemotherapy treatment
against breast cancer, the
informed consent form included
4 different cycles with at least
9 bullet points each outlining
different tests required to be
conducted during each cycle,
thus increasing the complexity
of the informed consent form.43
The phase III trials on the
“effect of triptorelin 2.5mg on
two biomarkers in patients with
advanced prostate cancer” and
on “single dose intravesical
apaziquone postoperative in
patients undergoing TURBT
for noninvasive bladder
cancer,” and the phase I
trial on “PD-L1 inhibition as
checkpoint immunotherapy
for neuroendocrine phenotype
prostate cancer” had less
AA enrollment due to similar
reasons.44,45,46 In a phase
II trial sponsored by the
National Cancer Institute to
examine “temsirolimus with or
without megestrol acetate and
tamoxifen citrate in treating
SOCRA SOURCE © May 2023
patients with advanced,
persistent, or recurrent
endometrial cancer” that began
in 2008 and completed in 2017,
participants were 8.5% AA and
91.5% white.47 This trial had
numerous requirements, such as
having measurable endometrial
carcinoma and prohibited prior
endocrine therapy, increasing
the level of health literacy that
requires the understanding
of various hormone therapies
and their effect on endometrial
carcinoma. In another phase
II trial sponsored by the
Dana Farber Cancer Institute
assessing the combination of
nivolumab and cabozantinib
for metastatic triple-negative
breast cancer from 2017 to
2019, participants were 5.6%
AA and 83.3% white.48 The
phase II trial sponsored by the
Gynecologic Oncology Group
to look into “chemotherapy,
radiation therapy, and surgery
in treating patients with locally
advanced cancer of the vulva”
that was initiated in 2005
and completed in 2012, had
even fewer AAs with 3.4%
and even more whites with
93.2% participation.49 This trial
required participants to come to
the clinic daily for radiotherapy,
making it hard for patients
who live far away from the
clinical trial site. In a phase III
trial sponsored by the National
Cancer Institute to investigate
“bevacizumab and intravenous
or intraperitoneal chemotherapy
in treating patients with stage
II-III ovarian epithelial cancer,
fallopian tube cancer, or
primary peritoneal cancer” that
began in 2009 and finished
in 2016, enrollment was 3.3%
AA and 91.5% white.50 This
trial also required participants
to come to the site to receive