Sponsored Insight
Janssen Oncology scientists are committed to developing highly effective treatments for each person diagnosed with blood cancer. Unfortunately, understanding the impact of specific therapeutics has historically been limited due to the lack of diversity amongst those who are recruited to and participate in clinical trials. Though cancer does not preferentially affect white populations, the data collected on the safety and efficacy of cancer treatments have been derived largely from white patients with the disease.
In the U.S. for example, Black Americans represent 20 percent of those living with multiple myeloma but only account for six percent of participants in clinical trials. The insights clinical trial data provide may, therefore, offer less value to underrepresented populations who bear a substantial cancer burden. To ensure that current and future cancer treatments are adequately investigated for potential benefit to all patients, Janssen is building long-term sustainable programs and strengthening collaborations aimed to enhance and foster diversity in clinical trials.
In advance of the American Society of Hematology (ASH) 2021 Annual Meeting, Leon Bernal-Mizrachi, M.D., Chief of Hematology and Medical Oncology at Winship Cancer Institute at Emory University, spoke with Craig Tendler, M.D., Global Head of Late Development, Diagnostics & Medical Affairs, Hematology & Oncology, Janssen Research & Development, LLC, to discuss the critical need to improve diversity in clinical trials.
Craig Tendler, M.D. (Tendler): Many of us are looking forward to rejoining the oncology community in person this year at the ASH meeting, where we are sure to see a lot of exciting new data. Dr. Bernal, when you look at the abstracts and consider what will be shared at ASH, what are you most excited about related to improving diversity in cancer research and care?
Leon Bernal-Mizrachi, M.D. (Bernal): I am of course always excited at ASH to see new results and to share the data from my own practice on advancements in multiple myeloma. What is most rewarding to me though is to see the presentations of the students and residents from underrepresented populations who we have supported through ASH with the Committee on Promoting Diversity. Watching these researchers participating in these meetings, presenting their findings and answering questions from extremely successful panels of researchers is a wonderful experience. It is hard to express the satisfaction of seeing the significant impact of our investment in these students and residents.
Tendler: We hear so much about needing to improve diversity amongst clinical trial participants, but you bring up an interesting point about diversity amongst practicing clinicians. Why is it so important that we train more physicians from underrepresented populations?
Bernal: Ultimately, we want to provide better treatment to all patients and eliminate existing health disparities. Ethnically-diverse clinicians play an important role in achieving these complex goals because there are a lot of patients who are cared for by physicians that are not from an underrepresented population, and they struggle to connect culturally with their doctors. This contributes to the pervasive lack of trust among patients from these communities. There are two negative impacts here – one, the patients may be less likely to follow the physician’s advice and therefore suffer worse health outcomes, and two, they may be less likely to participate in clinical trials that are run by principal investigators who are not ethnically diverse.
Tendler: Tell us a little about why it is so important that we enhance diversity in oncology clinical trials.
Bernal: First, there is a moral imperative. We are treating cancer populations that are diverse, so when we design cancer treatments, the foundation of those treatments should represent the entire population we’re treating. Second, participating in trials has several benefits that all populations should be able to access. Experimental treatments can of course be advantageous, but patients also receive exceptional care while participating in trials. Finally, clinicians should be able to access information on how treatments work in some of their patients versus others and understand if, for instance, certain treatments are metabolized differently in patients of different races. Hence, toxicities may differ according to race.
Tendler: From your perspective, where are we at this point in understanding the role and effects of our cancer therapeutics in underrepresented groups?
Bernal: The problem is that we don’t have enough data and the data we do have isn’t robust enough — so we just don’t know how these drugs work in underrepresented populations. A 2019 study showed that the variation for data among white patients is quite small, but it is huge among underrepresented populations. In essence, the paper demonstrated that our sample sizes for patients from diverse groups have been so small that we really just don’t understand how cancer treatments work in these populations.
Tendler: Patients’ trust in their physicians is something you mentioned as important for reducing health disparities, but trust is such a complex issue. In your experience, why is it sometimes difficult for patients to establish such trust, and what are concrete ways that trust can be strengthened?
Bernal: Many patients from underrepresented groups view the entire healthcare system with skepticism and feel that they are just products that the system uses for its own advantage. It is our job to make sure that patients understand that we are here to partner with them in their health, that we care about their outcomes, and that our recommendations to them come from a place of wanting to help them. At the end of the day, if we really are invested in their health and take the time to partner with them — to answer their questions between visits and make sure they’re getting what they need — our relationships with patients will flourish.
In terms of concrete ways to build trust, it’s important that we show our patients that we see them as individuals and that we are genuine in wanting to help improve their health. When I came to Grady, a lot of patients were not showing up for their appointments, and I wasn’t sure why. I had one patient who I felt I needed to work hard to retain to ensure he got the care he needed. I gave him my cell phone number so he knew he could reach me and that his care was important to me. Sure enough, he came back! I decided to give my number to all my patients, and now more than 90 percent come to their follow-up appointments.
Tendler: That makes a lot of sense. As sponsors of clinical trials, we often start by trying to eliminate barriers — for example, costs associated with travel to and from research centers. At Janssen, we have also found that we can sometimes help investigators and study coordinators start a trial at the community level simply by providing support — these centers have the scientific capabilities but are lacking funding and infrastructure.
Bernal: Yes — this is such an impactful way to stimulate clinical trials with more minority participation. From my experience, pharmaceutical companies have generally had a natural bias to run clinical trials in very traditional institutions because that is where they can find the adequate infrastructure and the experienced people. Having an organization like Janssen collaborate in other settings — such as community health systems — is making a difference. What’s important is not only the allocation of funds, but the time that is put into determining how to best enable these centers to run trials.
Tendler: That’s great to hear. There are definitely new challenges that we are learning to navigate.
Are there other important barriers to enhancing underrepresented participation in clinical trials in your view?
Bernal: Regulatory realities drive decisions in the pharmaceutical industry, so if an FDA approval of a drug requires that a certain percentage of underrepresented patients participated in clinical trials, there would be more incentive in the private sector to recruit a more diverse patient population to clinical trials. The drugs that the FDA approves each year currently enroll African American clinical trial participants at a rate of about 3 percent and Latino participants at a rate of about 6 percent, so I think it’s important that we have conversations about the role of health authorities in improving enrollment of underrepresented groups in trials.
Tendler: I agree with you that there are important barriers to address, and we are really focused on developing a comprehensive framework at Janssen that gives us a sustainable model for ensuring that adequate representation in our clinical trials is built into the “DNA” of each study. Part of that internal effort is around governance so that when teams come to us for approval to start a trial, a diversity strategy is already in place and is as important as other critical elements of a study — the design, assumptions and feasibility. This is now part of our standardized process for starting a trial.
Bernal: I am so happy to hear this. I have to tell you that being able to provide my patients who have essentially run out of therapeutic options with new opportunities for treatments that they can receive locally makes me so proud, and I am grateful when I see these patients pursuing these opportunities and receiving the appropriate treatments.
Tendler: Thank you, Dr. Bernal. Is there anything else on this topic that you’d like to share?
Bernal: I would say one critical focus should be promoting earlier diagnosis and screening in ethnically-diverse patients. Right now, these patients are generally being diagnosed at stages that are so advanced we can’t even offer standard of care. We need to close that gap so that we can diagnose earlier. In addition, because so many of these patients are ineligible for trials due to comorbidities, earlier diagnosis could help us promote their health so that they are eligible for and can participate in clinical trials. Finally, the investment in trials at the community level has a transformational impact on local health systems and should also be a focus of our efforts. For all of these, the support of industry partners like Janssen is critical, not only for making investments that inspire others to act but also leading by example to show others the ethical and clinical importance of the efforts you are making and the positive patient outcomes these efforts can deliver.
To learn more about Janssen Oncology’s presence at ASH and the company’s commitment to patients, visit Janssen.com/ASH2021.