February 2024 SOCRA Source Journal - Journal - Page 50
is defined as a trial participation
percentage for any ethnic
group that is greater than the
demographic percentage of the
same ethnic group for the entire
US population for the same
year.3 Ethnic demographics
were taken from the US
census. Within the general US
population from 2000 to 2010
to 2020, whites decreased
from 75.1% to 72% to 61.6%,
and AAs increased from 12.3%
to 13%, then decreased to
12.4%.1,4,5 In 2020, among
4922 study participants who
participated in clinical trials of
18 novel oncology drugs, white
participants were represented in
a greater proportion (general US
population = 61.6% vs clinical
trial population = 73.0%), while
AAs were underrepresented in
trials (general US population =
12.4% vs clinical trial population
= 5.0%).5,6 The gap between
AA participation in comparison
to the overall US population
is smaller in large, landmark
clinical trials conducted in
the early 2000s, but a smaller
percentage of AAs participated
in oncology clinical trials going
forward. One of the major
landmark trials regarding
cancer therapy, STAR (Study of
Tamoxifen and Raloxifene) on
breast cancer was conducted
from 1999 to 2006 and had a
demographic of 78.9% white
and 11.6% AA participants.7
In the BRiTE (Bevacizumab
Regimens’ Investigation of
Treatment Effects) study
conducted in 2004 on
metastatic colorectal cancer, the
enrollment consisted of 81.4%
white participants and 11.6%
AA participants.8 In both the
STAR trial and the BRiTE study,
there is an overrepresentation
of white participants compared
50
to the 2000 and 2010 US
Census Bureau’s report of the
general white population. Since
the early 2000s, the percentage
of AAs in the general US
population has remained largely
the same; however, in the more
recently conducted landmark
phase III trial CLEOPATRA
(Pertuzumab + Trastuzumab
+ Docetaxel vs. Placebo +
Trastuzumab + Docetaxel in
Previously Untreated HER2Positive Metastatic Breast
Cancer) that completed in 2018,
a total of 59.4% whites and
3.7% AAs enrolled.9 Although
there was a decrease in both
white and AA recruitment,
more whites participated
with 82.5% of representation
(59.4/72) whereas 28.4% of
AAs (3.7/13) were represented.
Moreover, the BATTLE-2
Program trial examining a
biomarker integrated targeted
therapy in advanced non-smallcell lung cancer participants
that was completed in 2020
reported a result of a total
of 88% white (vs. 61.6% in
the general US population)
and 9.5% AA (vs. 12.4% in
the general US population)
participation.10 This data shows
an overrepresentation of whites
and an underrepresentation of
AAs in comparison to the 2020
general US population report.5,10
The fact that the STAR trial had
put immense effort to advertise
the trial in cancer letters and
having a wide distribution
of trial sites across different
geographic locations may
have contributed to the 11.6%
outcome of AA participants.7
Unlike the STAR trial, the later
trials had limitations in that the
CLEOPATRA trial’s trastuzumab
was not widely known for the
breast cancer indication, and
SOCRA SOURCE © May 2023
the BATTLE-2 trial excluded
participants who did not agree
to a baseline tumor biopsy
procedure.11,12 Despite such
limitations, it is important to
shorten the gap between AA
participation in clinical trials
and the general AA population
in the US because it is difficult
to know how effectively a
medicine will work in specific
demographics—or whether it
will offer an additional risk to a
specific group of participants—
without meaningful
representation.13 According
to Gaelan Ritter, the head of
analytics innovation and digital
health at Bristol Myers Squibb,
the problem of AAs’ clinical trial
enrollment can be addressed
and solved by updated clinical
trial guidelines from the 2019
pandemic caused by the SARSCoV-2 virus.14
Impact of COVID-19 Overall in
the United States and Clinical
Trials
COVID-19 (coronavirus disease)
is a deadly respiratory infection
that first appeared in the United
States in March 2020.15 Over
20 million COVID-19 cases had
been documented by January
1, 2021, resulting in over
346 000 deaths in the United
States.15 The SARS-CoV-2
not only claimed millions of
lives and caused an increase
in hospitalizations, it also had
an impact on clinical trials.15,16
Because clinical trial participants
grew hesitant to travel to trial
locations and preferred to take
investigational drug treatments
at home as a result of the
virus’s rapid dissemination
through saliva from coughing
and sneezing, regulatory
authorities were urged to make
revisions to standard clinical