Bringing Clinical Trials to Minority Communities
With the goal of equity, The Loretto Hospital on Chicago’s West Side
is marshaling its forces against history and exclusion to bring clinical
trials to the largely Black and Latinx communities it serves.
Hospital leaders and staff are working to overcome minority communities’
long-standing mistrust of clinical trials, the result of, among other
things, the Tuskegee Study—a syphilis clinical trial held over 40
years and involving Black men—that operated without informed consent
and did not appropriately treat participants with the disease.
“In terms of the history, it’s been difficult to recruit,”
said Nikhila Juvvadi, MD, Chief Clinical Officer and Vice President of
Operations. “With the diversity of our team, it really helps with
our outreach. We want (community members) to participate on their own
terms. We want to make sure they understand this is not a huge academic
hospital, that they would not be lost.”
A community safety net hospital, Loretto has earned the trust of pharmaceutical
companies that typically work with academic medical centers. The hospital
is one of only a handful of Illinois hospitals offering clinical trials,
including for COVID-19.
Loretto is participating in three COVID-19 treatment trials: an antiviral
trial, antibody trial and outcomes study focused in improving testing
turnaround time. In December, the hospital will begin recruiting for a
vaccine trial.
“So many times, minority communities have not been included in clinical
trials,” said Lois Clark, MD, the principal investigator in Loretto’s
sickle cell trial. “There’s a dearth of information on how
certain medicines will behave in certain people.”
Loretto launched its first clinical trials in 2018, partnering with the
Oak Brook-based clinical research institute Affinity Health. Trials to
date include sickle cell disease, the heart condition pericarditis, low
testosterone, asthma, ulcerative colitis and Crohn’s disease.
To encourage community participation, Loretto President and CEO George
Miller visited over 100 community churches to build trust. The hospital’s
research ambassadors answer questions and guide trial participants at
every step.
The pandemic’s disproportionate impact on minority communities underscores
the need for minority inclusion in clinical trials. At the same time,
the federal government requires minority participation for any vaccine approval.
“There are reasons why minority populations may not trust the healthcare
system,” said Dr. Clark, who tells patients “it’s precisely
because of Tuskegee that this industry is very heavily regulated and that
every person has the right to know all the facts. Before anyone goes into
a clinical trial they get all the information.”