New Program Aims to Improve Diversity Among Investigators, Clinical Trial Participants

Robert Winn, MD

Bristol Myers Squibb (BMS) and the BMS Foundation are committing $100 million to support the Diversity in Clinical Trials Career Development Program (DCTCDP). A partnership with National Medical Fellowships (NMF), the program seeks to advance clinical trial diversity and improve access to quality health care in underserved patient populations in the United States while developing a more diverse medical workforce, including oncologists and oncologic investigators.

"This partnership with the BMS Foundation taps into 2 different things. There is the Pipeline Program, which is providing exposure to underrepresented minority medical students. That’s largely modeled after the Primary Care Leadership Program, but this will have a focus on pathways in clinical research specifically,” said Joy L. Jones, PhD, director of scholarships and programs for NMF. The 75-year-old organization is the only national group in the United States dedicated solely to providing scholarships to students in groups underrepresented in health care. “It’s the scholarship program, the Career Development Program, that takes us into an area where we’re providing support to practicing physicians. Outside of their residency, most of the support that we provide is for students in training. This expands the range of underrepresented minority health professionals that we are supporting.”

DCTCDP plans to train and develop 250 racially and ethnically diverse clinical investigators who have a demonstrated commitment to increasing diversity in clinical trials. Another 250 medical students from underrepresented minority groups will be introduced to clinical research career pathways. The program will assist investigators in building capacity and establish-ing new clinical trial sites in communities with diverse and heavily burdened patient populations.

Robert Winn, MD, director of the Massey Cancer Center at Virginia Commonwealth University in Richmond, will oversee the DCTCDP. Winn, 1 of only 2 Black directors of a National Cancer Institute–designated cancer center, said this initiative grew in part out of racial issues highlighted by the Black Lives Matter movement, but added that diversity among providers just makes good sense.“There’s the low-hanging fruit that we know from the literature. Folks who actually have people who look like them, sound like them, come from the same backgrounds—patients tend to feel that they’re getting better care,” he said. “But I actually take a different tack. I think that diversity in health care matters just like it does in businesses. Most businesses, most top-notch businesses, recognize that by having diverse groups at the table, bringing knowledge and bringing nuance to the table, strengthens the group.”

Moreover, it is well established that people of different races and ethnicities have unique biomarkers. For instance, African American women present with breast cancer earlier in life and with greater incidence before they are age 50 years, develop histologically more aggressive tumors that are at a more advanced stage at presentation, and have a poorer disease-free and overall survival than their White counterparts.¹ However, one reason investigators did not recognize that the presence of the BRCA gene was associated with increased risk for breast cancer among Black women is that these women, and Black patients in general, are often not included in clinical trials. Findings from the FDA on racial and ethnic participation show that approximately 80% of trial participants are White. Black Americans represent 13% of the US population but only 7% of participants in clinical trials.^2,3

If medicine is serious about eliminating racial disparities, Winn said, improving diversity in clinical trial participants is crucial. Not only will that improve medical knowledge, but participants in clinical trials will also receive more attentive coverage and have better outcomes.

However, many Black patients are often distrustful of the medical establishment, particularly older people with direct experience of being denied care because of race. That skepticism is prevalent across the culture.⁴

“There’s a new generation of misinformation and disinformation that has the potential of increasingly doing us harm. And I think that on the social net-works, there’s a fair amount of misinformation and disinformation that is actually dissuading people from even doing the things that might actually be practical just to save their lives,” Winn said. “This may seem like ancient history, but early in [the pandemic], last February, March, April, we had people talking about, ‘Black folks can’t get COVID-19.’ ”

To address these disparities, Winn said the DCTCDP will use “multilevel mentorship” to help young physicians develop soft skills that are vital but rarely taught. He added that this is the first program designed to help young investigators develop their knowledge beyond designing and carrying out a trial.“What we are also doing [in] this program, the first ever, is trying to develop a skill set of having those physicians actually also know how to create bridges and networks outside of the university setting and into the community,” he said. “Not only are we developing this cohort—they’re going to be amazing clinical trialists—we also are now arming them with an additional skill set of learning how to network and how to bridge within communities. “If we can have this next generation that is already steeped and trained with not only how to do clinical trials, but how to work with communities, how to engage communities, how to bridge communities, and how to network with communities, we may have much more effective trust within our communities to become involved with these clinical trials. I see that this workforce has the ability to really reduce health disparity.”Applications for the DCTCDP are open until July. Eligible candidates must hold the degree of MD, MD/PhD, DO, or DO/PhD and have an interest in clinical research in hematology and/or oncology, cardiovascular disease, and immunologic disorders. In addition, they will reflect the National Institutes of Health (NIH) definition of early stage investigator and the NIH definition of underrepresented populations in the US Biomedical, Clinical Behavioral, and Social Sciences Research Enterprise or have a demonstrated commitment to increasing diversity in clinical trials. To learn more about eligibility and program details, please email DCTCDPinfo@nmfonline.org.

References

1. Richardson LC, Henley SJ, Miller JW, Massetti G, Thomas CC. Patterns and trends in age-specific black-white differences in breast cancer incidence and mortality—United States, 1999-2014. MMWR Morb Mortal Wkly Rep. 2016;65(40):1093-1098. doi:10.15585/mmwr.mm6540a1
2. US Census Bureau quick facts. US Census Bureau. Accessed January 18, 2021. https://www.census.gov/quickfacts/fact/table/US/PST045219
3. 2015-2019 drug trials snapshots summary report. FDA. November 2020. Accessed November 20, 2020. https://www.census.gov/quickfacts/fact/table/US/PST045219
4. Jacobs EA, Rolle I, Ferrans CE, Whitaker EE, Warnecke RB. Understanding African Americans’ views of the trustworthiness of physicians. J Gen Intern Med. 2006;21(6):642-647. doi:10.1111/j.1525-1497.2006.00485.x