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KU Medical Center strives to increase diversity in clinical trials

International Clinical Trials Day celebrates the accomplishments of human research studies, but diversity in those studies remains a challenge.

The race to fight COVID-19 gave the public a glimpse into the complex process of using laboratory research to develop vaccines and treatments for people. Critical to moving that research out of the lab and into the clinic are clinical trials, the research studies that test newly designed treatments and vaccines in humans for safety and effectiveness.

International Clinical Trials Day, celebrated May 20 every year, recognizes the researchers who design and the staff who conduct those trials, for all diseases, and the people who volunteer to participate in them. Without them, scientific discoveries would never make it out of the lab and into the lives and bodies of patients to improve their health.

Across the University of Kansas Medical Center, more than 40,000 people have participated in clinical trials over the last four years. And from January through April of 2022, more than 2,000 people have participated in one of the 700 clinical trials active at KU Medical Center, putting the medical center on track for its most productive year yet.

But increasing the number of participants isn’t enough. On May 17, the National Academies of Sciences, Engineering and Medicine released a report calling the need to recruit from people more racial and ethnic groups into clinical trials “urgent.” Differences between people can often mean different responses to the same treatments and therapies, which is why diversity in clinical trial participants—people of different ages, races, ethnic groups, sexes and genders—is crucial.

“Clinical trials set the stage for helping us advance medical care,” said Mario Castro, M.D., MPH, director of Frontiers Clinical and Translational Science Institute at KU Medical Center and vice chair for clinical and translational research at KU Medical Center. “The pandemic taught us how important it is to be prepared, as we quickly had to develop and implement clinical trials to make the vaccines and treatments that are now available for COVID infection. But we also had to make sure those enrolled in the studies were diverse and reflected the populations most impacted by the pandemic.” 

Achieving diversity in trial participants is necessary for the study of many diseases. Earlier this year, The University of Kansas Cancer Center launched a media campaign to encourage minority participation in cancer trials. Just 2.9% of all participants in U.S. cancer trials are African American--yet the African American population of the United States is more than 13%. And despite being more than 18% of the U.S. population, Hispanic/Latinx individuals are less than 7% of clinical trial participants in cancer drug trials.

Diversity helps ensure not only that new treatments are effective for all people, but that all people have access to the experimental drugs available only through such trials. “We offer a wide range of leading-edge trials that are not available anywhere else,” noted Roy A. Jensen, M.D., vice chancellor and director of The University of Kansas Cancer Center. “By participating in a clinical trial, you have access to potentially effective treatments not available elsewhere.”

The University of Kansas Alzheimer’s Disease Research Center is pressing for increased diversity across numerous studies. There is an especially urgent need for African American participants in Alzheimer's clinical research because they are twice as likely as non-Hispanic whites to develop the disease.

"With more participation by different groups, there's also an opportunity for us to understand why we have these disparities," said Jeffrey Burns, M.D., professor of neurology and co-director of the KU ADRC. "Coming to a better understanding of that is crucial. Then we can work to reduce those disparities, which comes back to having drugs that work for everybody, or those disparities will only worsen."

Ashley Carlson, assistant director of Research Training & Communications at KU Medical Center, who oversees training for researchers about the myriad government rules and requirements for federally funded clinical trials, pointed also to the efforts the medical center is making by reaching out to underserved populations directly. 

“We have folks like the Frontiers Community & Collaborator Core team, who are out on the ground talking to communities that have been left out of research, working to get them engaged, and partnering in the research process,” she said. “[Diversity] is on everybody's mind right now, from the people who are working on individual trials to the administration behind it. The whole field is keenly aware of the legacy behind the lack of diversity and representation in trials. And we're definitely mindful here in our work as well.”

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