The need for diversity in clinical trials has come to an inflection point, with the FDA issuing draft guidance for how trial sponsors can enroll more ethnically and racially diverse patients and more companies delivering plans for achieving these goals.
Despite the increased attention and clear need, many pharma and biotech companies still haven’t shown that their efforts are working.
That’s not the case with Johnson & Johnson Innovative Medicine (formerly Janssen), which has been confronting the issue since 2018.
“This has been something that's been with us for quite some time,” said Denise Bronner, director of diversity, equity and inclusion in clinical trials at Johnson & Johnson Innovative Medicine (JJIM). “This is something — long before the FDA had released any guidance [and before] the political and social issues that happened in 2020 with COVID — the company was already starting to think about.”
The company has considered ways to make clinical trials “reflect the real world” to advance science, fill “big gaps” in research and increase access to effective medicines to underserved populations and communities, Bronner said.
“As a patient, you want to know that what you’re taking works for you,” she said. “And if someone like you was never included in the data, but this drug is approved, how would you take that? Would you even want to take that type of medication?”
“There are persistent [challenges], so we have to acknowledge that, as an industry and as a sponsor, but we also have to demonstrate what we’re doing differently."
Director, diversity, equity and inclusion in clinical trials, JJIM
Now, the company is seeing its efforts result in measurable change. For instance, it has already exceeded its goal of enrolling 554 Black, indigenous, and people of color (BIPOC) patients in six immune-mediated inflammatory disease studies by the end of the year. The pharma giant hit that milestone in July and by October, exceeded the goal even further, enrolling 853 patients who self-identified as non-white, including Black, Asian, multiracial, Native Alaskan/American and Hispanic non-white patients. Those numbers mean these patients represent nearly half of total enrollment across those studies in 2023, which far exceeds the 15% to 20% typically considered “diverse enrollment” by the industry.
PharmaVoice spoke with Bronner about some of JJIM’s strategies for success and six approaches that have been key.
Invest in education
Improved recruitment starts with awareness and education. One of the ways JJIM has tried to advance these is through Research Includes Me, a website that’s disease and trial agnostic and aims to educate people about clinical research, expectations, patient rights and community impact. It also includes a trial finder tool.
Restrictive inclusion/exclusion criteria that limit study participants only to people who haven’t had previous exposure to hepatitis B and C or require lab results to be within a certain range can be a major barrier to recruiting certain groups of patients, Bronner said. Other elements of the study protocol, such as site frequency, can also hamper recruitment.
Historical protocols and inclusion/exclusion criteria can be adapted and broadened to allow more diverse participation.
Improve study site selection
Instead of only considering study sites in the U.S., Canada and Europe, Bronner said JJIM has taken a global approach to improve representation.
“We've tried to expand to have deeper ties with the Asia-Pacific region, [and looked] into Latin America and even using African nations to help with recruitment,” she said. “Having such a large country footprint has allowed us to get representation across the board.”
And instead of revisiting the same study sites again and again in the U.S., Bronner said sponsors can use claims data alongside census data to map where target patients live and look for sites nearby “to meet the patients where they are,” she said.
Use robust recruitment tactics
Even with optimized protocols and site selection, recruitment isn’t guaranteed. JJIM works with sites to discern whether their materials and imagery reflect the kind of patients they want to recruit; provide educational materials about the trial, disease and clinical research; and train the staff around cultural competency using scenario-based training. The company also engages DEI-focused vendors that have access to and trust within communities to disseminate information.
Focus on retention as well as recruitment
Recruitment is only half the battle, and sponsors also have to make sure patients stick with them. Bronner said companies can compensate patients in many ways including transportation services, child and elder care, and connecting them with support groups. A sponsor can also provide “multiple touch points for patients,” for constant communication, such as reminding them of their next visit and answering questions.
JJIM also contracts with vendors who provide “study buddies,” who are patients’ point of contact from start to finish. Bronner notes that although the perception is sometimes that participants of color might have higher dropout rates, the opposite is actually true.
“We have seen that once a patient from a BIPOC community has come into our study, the dropout percentages are much lower than their white counterparts, and that is because they're finally getting the type of care they’ve been seeking,” both from the therapy itself and the ongoing check-ins with healthcare providers, Bronner said.
Understand that trust issues are not only historical
While BIPOC patients often mistrust the medical establishment, the reasons why aren’t limited to historical incidents like the Tuskegee syphilis study. There are ongoing issues impacting patient perception right now including high-profile examples of perceived challenges getting adequate care. Serena Williams, for example, suffered a medical complication after childbirth that she said was initially brushed off.
“There are persistent things that are happening as well, so we have to acknowledge that, as an industry and as a sponsor, but we also have to demonstrate what we're doing differently to address it,” Bronner said.