February 2024 SOCRA Source Journal - Journal - Page 53
community brings to the
forefront the need to provide
robust Informed Consent Forms
(ICF) in clinical research settings,
as well as provide outreach
and education on modern
Good Clinical Practice (GCP)
safeguards.
Furthermore, clinical trials are
largely dependent on access
to financial and logistical
resources. Participants with
an annual household income
below $50 000 have 32% fewer
chances to take part in clinical
trials.31 According to the 2010
Census Bureau report, the
median household income of
AAs is $32 068, which makes
it difficult for AA participants
to afford travel expenses to
trial sites and have additional
diagnostics tests for clinical
trials.32 Although the 2020
report shows a median income
of AA households as $45 870,
which is an increase from 2010,
it is still below the $50 000
mark.33 In the breast cancer
clinical trial study comparing
participation rate by race and
income, non-Hispanic Blacks
reported 6% less participation
than non-Hispanic whites under
the lower range of median
household income of less
than $38 000.25 Although both
whites and AAs showed greater
participation willingness rate
as their income increased, the
difference in the willingness to
participate in the trial between
AAs and whites increased to
34% less participation for AAs
under a higher range of median
household income of greater
than or equal to $63 000.25
Such increase in the difference
of willingness to participate
indicates that the higher
the income, the higher the
participation rate in oncology
clinical trials for both races,
but less of participation from
AAs compared to significantly
increased participation from
whites.
In addition, AAs have low
health literacy, which may
be contributing to their
lack of oncology clinical
trial participation. The 2003
National Assessment of Adult
Literacy reports that 58% of
AAs, compared to 28% of nonHispanic whites, had basic or
below basic health literacy.34
One study compared the
effects of low health literacy
in AAs versus whites and
Latinos and found that low
health literacy had a more
pronounced effect on AAs than
the other comparator groups.26
Five hundred participants of
white, AA and Latino cohorts
(n=1500) were asked to rate
on a scale of 1 (lowest) and 4
(highest), their willingness to
donate biospecimens to clinical
research.26 When health literacy
was low, the average willingness
among AAs was 2.5 versus 2.8
in whites and 2.9 in Latinos.
Conversely, at high levels of
health literacy, the willingness
to donate biospecimens to
clinical research was similar
for AAs (2.8), Latinos (2.7),
and whites (2.8).26 The lack of
health literacy is associated with
understanding the informed
consent form given prior to
clinical trial participation. In
a study that assessed 26% of
whites and 24% of AAs in their
comprehension of the informed
consent forms, 46.1% of whites
and 28.6% of AAs required 1
pass, meaning 1 adjustment
to the informed consent form,
while 11.5% of whites and
30.6% of AAs required 3 or
more passes.27 The study result
depicting fewer AAs grasping
the informed consent form with
1 pass and more AAs grasping
the informed consent form with
3 or more passes illustrates that
AAs require a more simplified
version of the informed
consent form.27 The simplicity
of the informed consent form
becomes problematic when it
comes to oncology clinical trials.
In a PubMed published article
that examined 54 ICFs for phase
I oncology trials approved by
the local Investigational Review
Boards from 2011 to 2013, the
median length was 20 pages in
which 74% of the forms stated
no benefit to participating,
22.2% of the forms stated
unknown frequency of risks, and
25.6% of the forms stated out
of pocket cost requirements
for the trials.36 Moreover, the
complicated study designs and
dose escalation descriptions
were discussed over several
pages in the forms, distracting
the participants from significant
information on survival and
treatment-induced adverse
events and from making an
informed choice regarding
participating in the trial.36,37
Principal Investigators (PIs) and
study site staff must be aware
of the challenges of properly
educating low-health literacy
participants about all ICF
components and ensuring that
they understand their risks and
responsibilities.
The lack of proximity to clinical
trial sites places a larger
economic burden on AA
participants.38 In the United
States, oncology clinical trials
are not distributed universally
across geographic areas.38
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