February 2024 SOCRA Source Journal - Journal - Page 49
JOURNAL ARTICLES
A Systematic Review of Factors
Hindering African American
Participation in Oncology Clinical
Trials and the Implications on
Representation Through Trial
Decentralization Methods
Recommended During SARSCoV-2
Lee E, Emerson J, Douglass M
Abstract: Subject participation is critical for the introduction of new pharmaceuticals for clinical use; however, the
rules and stringent requirements that come with trial participation have disproportionately favored white participants
compared to minority groups. Accurate representation of participant populations in clinical trials is important
to obtain the widest clinical application possible. Enrollment demographics should reflect the susceptibility and
prevalence of specific disease states in similar ratios to the general population. Numerous guidelines have been
released by the regulatory authorities to increase the diversity of clinical trial participants; however, the gap between
whites and African American (AA) enrollment still exists. The recent outbreak of SARS-CoV-2 has pushed regulatory
authorities and pharmaceutical companies to further address the disproportionate representation of race in clinical
trials. Pandemic strategies allowing for decentralized and flexible trial participation may also result in improved
outreach to underrepresented patient populations. If implementing over the long term, decentralization may
provide a promising methodology for improving minority representation. A systematic review was completed for
qualitative research studies published on electronic databases reporting data relevant to minority recruitment and
clinical trial participation. The search was limited to English-language publications and filtered with various Medical
Subject Headings (MeSH) terms. Although oncology is one of the main illnesses that cause a significant risk of death
among AAs, oncology clinical trials have historically been recruiting fewer AAs than whites due to AA’s little trust
in pharmaceutical companies and economic factors. With an increasing number of participants entering oncology
clinical trials during the pandemic, adjusted clinical trial guidelines by the Food and Drug Administration (FDA)
and the National Cancer Institute (NCI) are now being utilized by pharmaceutical companies to directly address AA
participation barriers and ensure the most accurate clinical applicability for a wide range of population factors.
BACKGROUND
History of
Underrepresentation of
African Americans in Oncology
Clinical Trials
Clinical trials are critical to
our society’s health and
medical process, but the
disproportionate racial
representation in clinical trials
between AAs and whites
continues to be a cause
of concern regarding the
applicability of clinical trial
data to AAs. According to
the US Census Bureau, whites
are defined as individuals
with ancestry from one of the
indigenous populations of
Europe, the Middle East, or
North America. The US Census
Bureau groups AAs and blacks
together and defines either
as individuals originating from
any of Africa’s Black racial
groups.1 Underrepresentation is
defined as a trial participation
percentage for any ethnic
group that is less than the
demographic percentage of
the same ethnic group for the
entire US population for the
same year.2 Overrepresentation
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