Recognizing a lack of diversity in their clinical trials and research, St. Louis-based Ascension set out to improve in this area, and has made strides that have recently received recognition. This "mission-aligned" work has been a focus for Frederick Masoudi, MD, chief science officer at the health system, who began his role in 2021.
Dr. Masoudi told Becker's he's specifically been involved in developing a national structure to help enable research across Ascension, which includes improving the representativeness of populations that are enrolled in clinical trials.
"Ascension's mission is to care for the poor and vulnerable," he said. "This work is entirely aligned with our long-standing mission."
The work began by measuring how the health system was doing in this area. Ascension adopted an enterprisewide clinical trials management system, which provided information about populations that were enrolling in clinical trials across the organization.
"I was happy to see that as we've aggregated those data, that the populations we enroll in clinical trials with respect to race and ethnicity very closely mirror the population for which we care for, which is a good place to start," said Dr. Masoudi.
One example he cited was a clinical trial that supported colleagues within Ascension DePaul Services of New Orleans. The trial occurred at a clinic that serves a predominantly ethnic minority population and centered around a cognitive behavioral therapy app to improve diabetes control.
"They knocked it out of the park in enrolling individuals at DePaul," Dr. Masoudi said. "They have a very motivated and capable team. They have long worked in the community and have built trust there, which is a key component to engaging individuals in trials. As a result, the population enrolled in the clinical trial was completely transformed with respect to race and ethnicity."
Also, in Tulsa, Okla., the Ascension St. John Clinical Research Institute recently won the inaugural Global Site Excellence in Diversity Award from the Society for Clinical Research Sites for its work to advance diversity, equity and inclusion in clinical trials. The award, sponsored by Syneos Health, was given after the institute established a program called Bridging Diversity Together. The program began in 2019, and program efforts and partnerships, including with the Eastern Oklahoma National Black Nurse Association committee and Indian Health Care Resource Center, resulted in a 9.2% increase in enrollment of American Indian individuals; a 6.6% enrollment increase of Black individuals; and a 2.6% enrollment increase of Asian individuals.
"This is occurring in an evolving landscape where the FDA is increasingly interested in the diversity of clinical trial participants," Dr. Masoudi said. "This is an opportunity for us to work with sponsors in this respect and improve the generalizability of the results of trials. Because of Ascension's footprint and the populations we serve, we can be leaders in this respect."
Ascension, which operates care sites in 19 states and the District of Columbia, has no plans to lose focus on making strides in this area. Dr. Masoudi said the hope is that the health system can be working with sponsors of clinical trials to develop more innovative and meaningful approaches to enhancing enrollment in trials among different populations. He said Ascension is also working closely with its chief community impact officer, Stacy Garrett-Ray, MD, on these efforts.
Still, he acknowledged that many pieces play a role in the fundamental components of lack of representativeness, such as logistical barriers and needing to find the time during working hours to make an appointment.
"We can work with sponsors to develop and support approaches that address logistical barriers to participation," said Dr. Masoudi. "We can also contribute to trial design with the objective of minimizing the burden to participants."
Trust is a factor, as well, given the long history of mistrust among individuals who are racial and ethnic minorities around clinical research.
"Addressing these issues of mistrust and developing stronger bonds within the community is a really important piece to it, as well. It's something that we look forward to working with Dr. Garrett-Ray around," Dr. Masoudi said.
Representation among researchers could also play a role in clinical trial participation. A recent retrospective study from researchers at Boston Medical Center found that patients could be more willing to participate in clinical studies when the research staff is of the same race or ethnicity.
"DePaul is a good example of how a clinician who is known and trusted in the community and a research coordinator who looks like the individuals in that community contributes to participation," Dr. Masoudi said. "We recognize that trust is an issue we need to tackle head on, given that mistrust in research is entirely understandable given the history of research in underserved communities."
He also said Ascension will also remain focused on integrating research within clinical care, meaning working with clinicians and addressing the priorities that are most pressing for their patients and for them. The health system also remains focused on the importance of research in building robust programs and advancing the mission of the organization.
"There are increasing incentives to enhance the diversity of the populations that are engaged in research," he added. "More importantly, it's the right thing to do, and in our case, it is mission-aligned."