DIVERSE CLINICAL TRIALS
ECU sees success in racially diverse clinical trials for new medicines, treatments
The Brody School of Medicine at East Carolina University has experienced recent success in recruiting a diverse group of patients to participate in clinical trials for new medications and treatments.
Data shows that from March 2019 to March 2020, 202 patients participated in oncology clinical trials in ECU’s Division of Hematology and Oncology; 50% of them represented races other than white. The following year, 419 participants were accrued, and 56% represented races other than white. That year, 50% of clinical trials participants were Black or African American.
“Our patient population, as well as Brody’s mission, has led to our success,” said Susan Eubanks, clinical trials nurse specialist in Brody’s Division of Hematology and Oncology. “Part of our core values is to cultivate a clinical environment of robust learning, innovation and discovery. There have been trials with participants here in eastern North Carolina that have led to new treatments in diseases and in some cases where there were few options.”
Researchers and providers work to recruit a diverse participant base for clinical trials to ensure data and understanding of how new medications could affect patients of varying races.
Now, researchers and providers hope to build on that momentum for future clinical trials studies.
Providers and researchers in the school continue to seek minority participants in clinical trials for new and potential pharmaceuticals — and to collect invaluable information on how some treatments impact patients of various races.
Doctors want to ensure that the drugs they are studying match the demographics for all the patients who could rely on those medicines in the future — by including people from a wide variety of backgrounds and races in the studies.
“We all agree that as much as possible, the drugs we give should be approved through clinical trials that match the demographics they will be prescribed to,” Eubanks said. “There has been chemotherapy that has shown promising results in one country but doesn’t carry the day in another. So, overcoming this disparity — whatever the cause — is essential.”
One of the latest innovations in oncology is the use of immunotherapy, the treatment of disease by activating or suppressing the immune system. Data that reviewed participation in those trials showed that less than 4% of participants in key immune therapy trials were African American.
“This is a problem,” Eubanks said. “Given the low representation we can’t predict if there will be a differences in outcomes related to differences in response from tumor biology. It is not highly understood why we see differences in drug efficacy and toxicities among different ethnicities, but it drives the point home, we need to do all we can to include the best representation of our population when bring new therapies to market.”
Dr. Darla Liles, professor and division chief of ECU’s Division of Hematology and Oncology, said diseases like prostate cancer and colorectal carcinoma see more African Americans impacted than other races, and the diseases begin earlier in those patients as well.
“Also, the distribution of the DNA mutations are different across races,” she said. “We might have a drug that works wonderfully well in Caucasians but not so well in African Americans or Hispanic individuals because of these different DNA changes. But we only know that if enough minorities participate.”
Recruiting challenges
Even with the critical need for data that better illustrates potential patient outcomes, recruiting minority participants in clinical trials can be difficult.
“Accruing to clinical trials in general is difficult, but minorities are typically underrepresented in clinical trials,” Eubanks said. “This can be an access issue, a reluctance issue and, at times, both.”
There can be many reasons recruiting minority participants to clinical trials can be a challenge, Liles said, but keeping those reasons in mind and understanding that they vary from person to person help build trust.
Brody’s mission draws heavily on a theme of access for all: to a medical education, to health care, and to resources that can sustain health and wellness. That’s one reason access to clinical trials in the medical school is vital to the study and approval of novel treatments.
ECU’s Division of Hematology and Oncology is leveraging recent success in increasing diversity in clinical trials to ensure providers understand how new medications and treatments could affect patients of any race.
“Part of our commitment to the health care of all eastern North Carolinians is ensuring the pharmaceuticals and treatments that we study are safe and effective for every patient who may need them in the future,” said Dr. Michael Waldrum, Brody’s dean and CEO of Vidant Health. “Our efforts to widen the participant base in our clinical trials programs reflects the importance of thorough and inclusive studies that yield results that we are confident meet our mission.”
Liles said that people are more likely to trust providers and those running clinical trials if they feel they share common bonds with them.
“Several times when I presented a trial to a patient, afterwards the CRA has told me that they went to high school with the patient or knew them from church,” she said. “Being able to relate to the people who are treating you is essential.”
Education is key as well, Liles said.
“When I offer a trial to a patient, I often understand this is starting a conversation over several visits to ensure patients know about and understand what they are signing up for,” she said. “The consent forms for clinical trials are jam-packed with important information about the treatments, and sometimes people use that as a starting point for knowing what to ask about their treatment. I never regret giving a patient a consent form and talking to them about a trial. Even if they eventually decide not to do it ,they are better informed by participating in the process.”
Eubanks said the COVID-19 pandemic and reluctance by some to take the vaccine are a reminder of how to approach building trust in clinical trials.
“We must think beyond just education in the office,” she said. “We must reach people where they are.”
One way Brody is working to reach many different patients is having trials open for a variety of specialty care areas.
“The biggest step is understanding your population and having trials open for the specialty areas you see,” Eubanks said. “Brody has trials open with many specialties. In adult hematology/oncology we use databases and the tumor registry when approached about upcoming trials to help us determine if a trial is potentially feasible in our area. We also have the benefit of having local resources such are the University and Medical Center Institutional Review Board (UMCIRB) and leaders such as our associate dean for research and graduate studies, Dr. Russ Price, that provide expertise and infrastructure needed to offer clinical trials.”
Liles uses word of mouth to share clinical trial opportunities to patients.
“I often tell my patients about new and innovative trials that are on the horizon, even if they do not fit the criteria for the trial,” she said. “I think it is important for patients to understand that there are new things being developed all the time. Education is our best way to ensure patients know about and participate in trials.”
Liles also believes the combination of specialties and resources in the creation of the ECU Health brand will have a positive impact on the clinical trials program. With close to 1.4 million people in the system’s service area, there is promising potential to reach people through improved infrastructure for research opportunities.
“I hope ECU Health will streamline the process and the collaboration between Vidant and ECU,” Liles said, “so that we can reduce the time it takes to move trials out to our patients.”