By Diana Foster, Ph.D., Vice President, Diversity, Equity, and Inclusion, Society for Clinical Research Sites
The life sciences industry can, and should, be a driving force in improving diversity, equity and inclusion in clinical trials—but not the only force. Collaboration is key, as was reported in the recent Keynote/Fireside Chat at the SCRS Diversity Site Solutions Summit. Read part 1 of our session summary .
Part 2 of the discussion features Vice Admiral Jerome Adams, MD, MPH, TOTAL Diversity’s Chairman of the Board, and Lorena Kuri, MS, Head of Diversity Strategy at Bristol Myers Squibb, and Dr. Diana Foster, Vice President, Diversity, Equity, and Inclusion at SCRS.
Dr. Adams and Ms. Kuri provide insight into the barriers that prevent communities of color from participating in clinical trials—and how sites, researchers and government entities can address those challenges.
Dr. Foster: Operation Warp Speed, a federal effort that sped up development of COVID-19 vaccine candidates, was the most diverse clinical trial in history, at 30% diverse enrollment. What lessons did we learn from this?
Dr. Adams: “Part of what discourages people from getting involved in clinical trials—particularly BIPOC (Black, Indigenous, and people of color) people and those from vulnerable communities—is all the red tape involved in getting enrolled in a study. We needed to clear out the bureaucracy.”
“In addition, we needed to understand that just because a community has people of color, doesn’t mean that site in that community is going to enroll people of color. Therefore, it was better to find a site that was already enrolling at 40% and ask, ‘What do you need to get up to 50 or 60%?’ That was more effective for us than to find 20 sites that were enrolling at 3% and trying to get them to double to 6%.”
“Having the right people at the site, with the right passion and the right understanding, is key. We also need to ask questions such as, ‘How do we diversify the entire site and not just focus on clinicians?’”
Ms. Kuri: “It’s very important that we think about the research or the trial being inclusive by design. The eligibility criteria are inadvertently eliminating some patients that must be in the trial. We need to understand the impact of inclusion and exclusion, screen failures, and race and ethnicity.”
Dr. Foster: What does the FDA Draft Guidance mean for clinical trial sites?
Ms. Kuri: “The FDA is giving us, as sponsors, some structure to understand how we are performing and how we can recruit racial and ethnic minorities. That structure is guiding us to think about our goals, our eligibility criteria, what our patient enrollment plan looks like and how we’re going to be supporting the sites, and what we’re going to do if our efforts aren’t working. So that structure is guiding us as Sponsors to put more effort and thought earlier in the development process.”
Ms. Kuri also shared that the racial and ethnic categories currently in use are not inclusive enough, and the guidance is making us rethink how we collect the data. “Race is not only those five boxes and ethnicity— not only ‘Hispanic or Latino’ or ‘non-Hispanic or non-Latino,’” she said.
Dr. Foster: How can we understand and reduce barriers for clinical trial participation? What is the impact of the CMS (Centers for Medicare & Medicaid Services) change?
Dr. Adams: “CMS changed their guidance so that now Medicaid must cover study-related expenses. That’s huge. Before January 2022, Medicaid would not pay for medical treatment related to a clinical trial, whereas private insurance would. That was a real barrier to people participating in the study. Over 60% of the enrollment in Medicaid across the United States is people of color—the people we want in our studies.”
Dr. Foster: How do we ensure that research and trial protocol is inclusive by design?
Ms. Kuri: “At Bristol Myers Squibb, we have been trying a sustainable approach. We’re helping sites enroll more diverse patients by analyzing eligibility criteria, by helping some research sites to be trained, and by understanding how we can measure and track our progress and our performance.”
“We’re building cultural competence within our organization and with all our investigative partners. We’re maintaining relationships with advocacy organizations and with community outreach organizations that are already trusted voices in the communities that we want to serve. We’re teaching inclusive behaviors to Investigators. We’re highlighting the value of non-medical staff (such as community ambassadors and patient navigators).”
“We’re also trying to help patients walk through health literacy, but also civic literacy. We want to empower patients to challenge or to ask questions of their providers.”
Dr. Foster: What is the role of health equity in clinical trials?
Dr. Adams: “Equity is making sure people get what they need. Someone may not participate in a clinical trial because they don’t have transportation, childcare, or food to eat. They’ve got other priorities in their lives besides trying to help you get your drug approved.”
“So, we need to look at health equity as critical to increasing diversity in clinical trials. We need to look at increasing diversity in clinical trials as critical to health equity. The two are one and the same.”
Dr. Foster: How do we encourage accountability and self-assessment?
Dr. Adams encouraged all site to complete the Diversity Site Assessment (DSAT) tool. “It’s going to be very critical for training and support for sites,” he said.
Conclusion: Collaboration as the missing link
Ms. Kuri shared a quote from Malcolm X that appropriately sums up the impact of collaboration in improving health equity. She said, “If we change ‘I’ for ‘we,’ even illness becomes wellness.” Let’s hold this thought as we move forward and continue to build on our collective efforts.