Massive Bio co-founder and CEO Selin Kurnaz, PhD, participated in roundtable discussion on increasing diversity and inclusion in clinical research.
NEW YORK—Pharmaceutical companies and other makers of medical products should adopt new strategies and partners in order to enroll more diverse patient populations in clinical trials, said participants in a recent online panel discussion titled “Striving for Health Equity: Increasing Diversity and Inclusion in Life Sciences Clinical Trials.” The discussion, moderated by Liisa Eisenlohr, associate director of life sciences at the consulting firm Guidehouse, featured a half dozen industry experts with unique perspectives on the issue of diversity and inclusion in these critical research studies. The panel included Selin Kurnaz, PhD, co-founder, and CEO of Massive Bio, Inc., a leader in precision medicine and artificial intelligence-enabled, patient-centric clinical trial enrollment. “Increasing diversity and inclusion in clinical trials is in the DNA of our company,” said Kurnaz.
Clinical trials are designed to test the safety and efficacy of investigational drugs and other medical products. Historically, people from racial and ethnic minorities and other diverse groups have been underrepresented in clinical trials. That’s a problem since research indicates that people of different racial or ethnic backgrounds sometimes respond differently to certain medical products. To remedy this shortcoming, there is a growing movement underway in the research community to include more Black, Hispanic, Asian, and Native American people, as well as other people of color, in clinical trials.
However, Kurnaz argued that it’s essential to think even more broadly about how to make potentially lifesaving treatments being studied in clinical trials accessible to a wider population of patients. “Unfortunately, in the world of clinical enrollment, it’s not just about a particular race or ethnicity that is marginalized. Everybody is marginalized in terms of getting access to clinical trials,” she said.
For starters, says Kurnaz, consider that clinical studies are often conducted at large academic medical centers in urban centers. Yet, about 85 percent of adult oncology patients receive care at cancer clinics in smaller communities. Half of all cancer patients never hear about options for clinical trials from their oncologists. When a patient is told about a clinical trial, it’s almost always one being conducted at the hospital where they’re receiving treatment, which may not be the best choice. “So, at Massive Bio, we are expending a significant amount of effort to increase clinical research access in these community-based practices,” says Kurnaz. Moreover, Massive Bio works with cancer patients to overcome “last mile” barriers that can exclude them from participating in trials, such as financial and travel considerations.
Kurnaz stressed the importance of close collaboration with patient relations groups for reaching out to diverse populations, a sentiment echoed by panel member Erika Heiges, MPH, associate director, engagement strategy lead, for Bristol Myers Squibb (BMS). As an example, Heiges described BMS’s partnership with an advocacy group called Black Health Matters. One of this partnership’s initiatives focused on prostate cancer, which is 60 percent more common in Black men than White men. However, just four percent of Black males with prostate cancer in the United States enroll in clinical trials. Through grassroots community education programs held at locations such as barber shops and churches, BMS and Black Health Matters increased enrollment of Black men in clinical trials of new prostate cancer therapies to 17 percent. “We can’t do this without patient relations groups,” says Heiges.
In another innovative strategy, Novartis is working with the four historically Black medical schools in the United States to run clinical trials at those academic centers, said Kim Fookes, global head of diversity and inclusion in clinical trials for the pharmaceutical company. “In the long term, we are also supporting the next generation of diverse physicians and clinical trialists,” she said, with a goal of increasing the number of doctors and researchers who are people of color.
Also participating in the panel discussion were Binita Patel, M.Sc., global clinical project manager at Bayer, and Omer Abdullah, MD, associate vice president and head of medical advisors for the Americas clinical study unit at Sanofi. Dr. Abdullah noted that regulators are helping to create momentum in the effort to increase diversity and inclusion in clinical trials. For example, in April the U.S. Food and Drug Administration issued a draft guidance with recommendations for how developers of medical products should create race and ethnicity diversity plans designed to enroll study participants from groups that have historically been underrepresented in these studies. “It’s a great step in the right direction,” said Dr. Abdullah.