Critical Dose

When the FDA reviewed a pool of about 300,000 participants in its drug trials between 2015 and 2019, it found that Hispanic and Black patients made up just 13% and 7% of the trials, respectively. This was well below their national representation, with Census data reporting that 18.7% of the population is Hispanic and 13.4% is Black. These clinical trials are a critical element in the development of breakthrough therapies, but without representative diversity, the broad efficacy of the resulting drugs can be limited, says Scott Schliebner (MPH ’97). Schliebner has nearly three decades of experience in the life sciences and drug trials space and advises multiple companies in the field.

“The majority of clinical trial participants are Caucasian men. You don’t have great gender distribution, and you definitely don’t have ethnicity represented. And without diverse representation, you lose a good understanding of how a new therapy works, where it works, and who it works for. Therefore, our therapies are not as effective as they could be because we’re not necessarily connecting them with the right populations,” Schliebner says.

A lack of inclusion in drug trials also denies vital care to underserved populations, he notes.

“If we really want clinical trials to be a care option for people, we need to put them out there into the world. Whether you’re in Manhattan or rural Georgia, you should be able to access these new therapies—the same way you can shop on Amazon.”

Here, Schliebner talks to UtahMed about how the industry can improve inclusion—and what success might look like. 

HOW AND WHEN DID THE PHARMACEUTICAL INDUSTRY REALIZE IT HAD A CHALLENGE ON THE DIVERSITY AND INCLUSION FRONT?

The problem has been there for a while, but the realization seemed to coincide with the murder of George Floyd and the rise of the Black Lives Matter movement. As an industry, we started to look more closely at representation, inclusion, and diversity. We started to ask, “Are we providing access to everyone? Do people know what a clinical trial is or how to enroll in one?” There are also issues around trust. We’ve had lots of missteps in the past, governmental and otherwise, so if you’re of an ethnic minority and you’ve seen some atrocities, are you really going to sign up for a clinical trial? Or are you asking, “What’s going to happen to me?” 

There has been a strong emphasis on this for about three years. I’m hoping it isn’t a bright, shiny object or a flash in the pan and remains a point of emphasis for our industry. 

HOW CAN WE ADDRESS IT? WHAT CAN BE DONE TO MAKE THE TRIALS MORE INCLUSIVE? 

There are several things we can do to build awareness and educate people about clinical research’s treatment role. There are many people for whom this clinical trial process is very under the radar, and they might think that it’s an experimental, poking and prodding type of environment, when, in fact, it could be an excellent care option. 

New technologies can help with connecting to electronic medical and health records, enabling trials to better understand patients’ conditions and demographics. They can also help with enrollment and allow people to participate in clinical trials from anywhere—which should be part of the solution as well.

There are also many ways to increase diversity and representation that are non-tech: education, awareness, establishing a relationship with your physician, trust, authenticity, and communication. Those are the longer-term, foundational things that need to happen. 

WHAT WILL BUILDING THAT LONG-TERM FOUNDATION REQUIRE? 

Long-term relationship-building will require partnering and collaborating between patient advocacy groups and the pharmaceutical industry. It’s essential for the industry to actively engage with patient organizations, listen to their needs, and go beyond merely providing financial support for their annual events. Instead, they should ask, “How can we learn more about the patients’ disease and hear what’s important to them? How can we foster understanding about the drug development process?”

We need to show that we’re ethical. We need to build relationships. We need to listen to people. This is a long-term build.

“If we really want clinical trials to be a care option, we need to put them out there into the world.”

A Trailblazer Takes the Helm at NIH

Cancer surgeon Monica Bertagnolli, MD ’85, tapped to lead the National Institutes of Health.

Monica Bertagnolli, MD ’85, a cancer surgeon, was the first female director of the National Cancer Institute (NCI). She was also the first woman to lead the Dana-Farber Cancer Institute’s surgical oncology division in Boston. Now, she will be the first surgeon to lead the National Institutes of Health (NIH), its second female director, and the first medical doctor trained in Utah to serve in this important national leadership role.

Named by the U.S. Senate as the 17th NIH director in November, Bertagnolli will oversee the largest public funder of biomedical research in the world. The NIH has a budget of more than $47 billion and comprises 27 separate institutes and centers. “It’s no surprise to many that an alum from the Spencer Fox Eccles School of Medicine has become the nation’s top scientific leader,” said Michael L. Good, MD, CEO of University of Utah Health and A. Lorris Betz Senior Vice President for Health Sciences. “We’re proud that her medical education here helped set the trajectory for an incredible and accomplished career.” 

The daughter of first-generation Italian and French Basque immigrants, Bertagnolli grew up on a 4,800-acre ranch nestled along the foothills of the Wind River Range in southwestern Wyoming. She received her undergraduate degree in engineering from Princeton University but soon found herself drawn to medicine. She applied to and chose the University of Utah largely because of its immunology program. But a funny thing happened on the way to her medical degree: she fell in love with surgery. 

“I signed up for surgery as my very first clinical rotation, just because I wanted to get it out of the way,” Bertagnolli told the ASCO Post. “I still vividly remember my first day in an operating room because I immediately knew that’s where I belonged.”

After Bertagnolli graduated from the U’s medical school, she trained in surgery at Brigham and Women’s Hospital and was a research fellow in tumor immunology at the Dana-Farber Cancer Institute. Prior to her appointment as NCI director, Bertagnolli was a professor of surgery at Harvard Medical School and chief of the Division of Surgical Oncology at Brigham and Women’s Hospital and Dana-Farber Cancer Institute. She also served as chair of University of Utah’s Huntsman Cancer Institute External Advisory Board. In that position, she played a key role in advising Huntsman Cancer Institute on strategy for its cancer research efforts and particularly the institute’s enhanced commitment to the Mountain West.