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Bringing Clinical Trials to Minority Communities

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.”