February 2024 SOCRA Source Journal - Journal - Page 56
participants’ unwillingness to go
outside due to COVID-19.17,18
The NCI specifies the allowed
research activities, such as
physical exams, laboratory
assessments, and drug therapy
with non-investigational agents,
such as standard radiation
therapy.18 Although injectable
investigational agents are
still required to be given at a
registered participating trial
site, participants can choose
to go to the trial site closer to
their homes.18 Investigational
agents administered orally
can be shipped directly to
participants’ homes.18 The
FDA guidelines allow for
home infusion for injectable
investigational products as
long as risk assessment and
storage conditions are carefully
examined.17 These changes not
only protect participants’ safety
from the SARS-CoV-2 virus but
also provide a solution to the
associated economic barriers,
granting AAs more freedom to
participate in clinical trials by
saving the cost of travel.
Ever since the announcement
of the updated guidelines in
2020 and the occurrence of
COVID-19 in 2019, a change
in clinical trial population
demographic data is beginning
to appear. In a phase II study
conducted in 2019 and
sponsored by the Medical
University of South Carolina
to “evaluate whether a new
patient navigation intervention
can decrease delays starting
postoperative radiation therapy
after surgery” for participants
with head and neck cancer,
participation was 30% AA
and 70% white.54 In the study
56
with the same sponsor and
same intervention to a more
specific head and neck cancer
population conducted in
2020, participation increased
a little more to 33.3% AA and
decreased to 66.7% white.55
These two studies focused
on participants answering
questionnaires that can easily
be done at participants’
homes, solving the barrier of
AA households’ location far
from the clinical site. Moreover,
the studies had a very small
population pool of 11 and
18 participants respectively,
so more data needs to be
collected from ongoing and
future clinical trials to determine
the effectiveness of changed
FDA and NCI guidelines in
improving AA participation.
Not as much as the previously
mentioned two trials but with
a greater population number,
the trial began in 2020 “using
Electronic Medical Records
(EMR) to Assess Effectiveness
of Afatinib (Gilotrif) Following
Pembrolizumab and
Chemotherapy in the Treatment
of Metastatic Squamous
Cell Carcinoma of the lung”
reported a total of 26.5% (n=53)
AA and 66% (n=132) white
participation.56 Utilizing EMR
helps decrease the burden
of having participants travel
back and forth to the trial sites.
The enrollment rates of 30%,
33.3%, and 26.5% of AAs are
an increase from less than 9%
participation of AAs in the
clinical trials conducted preCVOID era.
SOCRA SOURCE © May 2023
Actions Taken to Facilitate
Enrollment of AA and
Minorities During COVID-19
Applying the FDA and NCI
guidelines in clinical practice,
numerous pharmaceutical
companies and national
institutes are currently taking
action to increase diversity in
the clinical trial population and
more specifically within the
therapeutic area of oncology.
The National Cancer Institute
developed The Community
Clinical Oncology Program
to strengthen minority
enrollment in cancer research
studies, providing community
physicians greater access to
oncology clinical trials.57 In May
2021, Sanofi Pharmaceuticals
collaborated with technology
company TrialSpark to expand
AA participants’ enrollment by
establishing relationships with
both community physicians
and private physicians
within the underrepresented
communities where the clinical
trial participating population
percentage is a lot less than the
percentage accounting from
the general population, thereby
driving quicker trial execution
with wider study access toward
AAs.58 Sanofi Pharmaceuticals
also makes efforts to utilize
participant advocacy
groups to engage with the
underrepresented community
which recently resulted in
a five-fold increase in AAs’
recruitment for their clinical
trials.57 Eli Lilly is currently
requiring their clinical studies
to involve at least two study
sites in areas where more than
75% of the population is nonwhite.59 Genentech is taking an
approach to have their new trial
sites located in institutions that
had served numerous minority