February 2024 SOCRA Source Journal - Journal - Page 51
trial protocols.15 The Food and
Drug Administration and the
National Cancer Institute were
quick to make adjustments in
oncology clinical trials especially
due to a rise in new participants
entering oncology study sites
during the pandemic. According
to Medidata, oncology is the
only therapeutic area to see
an increase in the number
of participants participating
in clinical trials amid the
SARS-CoV-2 outbreak.16
In the initial months of the
COVID-19 pandemic, clinical
trial enrollment dropped
sharply with a 40% decrease
in April of 2020.16 However,
due to the implementation
of mitigating procedures, the
enrollment had improved to
-28% year-over-year by May
of 2020.16 Even though the US
experienced a 16% decrease
in new participants enrolling
at trial sites overall, by July of
2020, the oncology therapeutic
area had recovered, and
enrollment increased 20% over
the average pre-COVID-19
monthly enrollment.16 The
modifications to trial protocols
made by the FDA and NCI are
shown in March 2020 Guidance
for Industry, Investigators, and
Institutional Review Boards and
in March 2020 Interim Guidance
for Patients on Clinical Trials
Supported by the NCI Cancer
Therapy.17,18 The guidelines’
recommendations for clinical
trial protocol amendments
are significant to ensure data
integrity and safety of cancer
participants who still enroll in
trials despite the pandemic.
With the history of a substantial
gap between the number of
whites and AAs participating
in clinical trials and the recent
pandemic outbreak and
revised guidelines, the research
questions for this systematic
review are (1) What are the
prominent reasons behind the
lack of participation in oncology
clinical trials by African
Americans in comparison to
whites even though there
is a higher prevalence and
mortality? and (2) How can
recent guideline amendments
from COVID-19 facilitate African
Americans’ participation and
what is the current progress of
the intervention?
Methods
A total of 190 publications
were reviewed and filtered
with 4 databases and 4 MeSH
terms. The searched databases
included PubMed, Cochrane
Central Register of Clinical
Trials, Google Scholar, and
MEDLINE. The MeSH terms
incorporated “African American
participation,” “cancer clinical
trial,” “decentralized clinical
trials,” and “COVID-19
amendments.” Inclusion
criteria were studies on AA
enrollment in oncology clinical
trials, protocol amendments,
and their contribution to AA
participation. Exclusion criteria
were studies without published
demographics, studies that did
not sub-categorize AA data,
and studies conducted outside
the United States. The scope of
the search was limited to articles
published between 1998 and
2022. The search terms yielded
86 results from PubMed,
70 from Cochrane Central
Register of Clinical Trials, 10
from Google Scholar, and 24
from MEDLINE. After removing
duplicates across multiple
databases and filtering out
articles that were not capable
of answering the research
questions, the total number
of eligible articles was 60. Of
the 60 publications, 2 were
retrieved from the FDA and
NCI for guidelines regarding
COVID-19-related trial changes.
Another 7 publications centered
on the specific factors hindering
AA participation in oncology
clinical trials.19,20,21,22 Among
studies within the 7 publications
delving into each hindering
factor, 1 was specific to AAs,23 1
compared AA to whites,24 and
3 examined AAs against whites
and Latinos/Hispanics.25,26,27
The other 54 publications were
divided between population
data among ongoing and
previous oncology clinical trials
obtained through clinicaltrials.
gov, the trend in trial
participation data analyzed by
Medidata, and pharmaceutical
companies’ efforts to solve
the lack of AA representation
nowadays portrayed through
press releases. In addition,
the 2020 United States racial
demographic data were
compared to the demographic
makeup of clinical trial
participation published by the
FDA of the same year.
RESULTS
Among the 63 articles that
were reviewed, the 2 most
common reasons for AA’s lack
of participation in clinical trials
were trust and socioeconomic
factors. The socioeconomic
factors which primarily affected
participation were income,
health literacy, and geographic
location. Seven journals
discussed The Tuskegee Study
of Untreated Syphilis in the
Negro Male experiment dating
back to the 1930s.28 This study
was a major historical event that
generated an enduring lack
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