What it Takes to Truly Diversify Clinical Trials
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It's no surprise that medications work differently in different people. Everything from age to weight to genetic makeup can play a role in an individual’s response to treatment.
Yet there's a stunning dearth of information about how different treatments may affect different racial and ethnic groups. That's due in large part to the fact that people of color have been historically underrepresented in clinical trials, which are studies that evaluate the safety and efficacy of investigational medications. And that paucity of data only exacerbates many of the other health disparities that people from historically marginalized groups face, like a lack of access to care, lower rates of health insurance coverage and higher rates of certain severe diseases.
A 2021 analysis revealed that more than 40% of 230 U.S.-based trials didn’t report the race of participants, and almost 65% didn’t report ethnicity. Of those that did report race, 78% of participants were white, while just 11% were Black, 6% were Asian and less than 1% were Native American—and in studies reporting ethnicity, only 11% of participants were reported as Hispanic or Latino.
These disparities pose an urgent problem that Johnson & Johnson is meeting head-on. In 2020, the company launched Our Race to Health Equity—a commitment to close the racial health gap so that the color of your skin is not a determinant of your access to care, quality of care or health outcomes. This initiative involves working to increase diversity in clinical trials.
“We should be designing clinical trials for the patients we'll treat or who will use our treatments,” says Staci Hargraves, Vice President, Patient and Portfolio Solutions at the Janssen Pharmaceutical Companies of Johnson & Johnson, and Executive Sponsor of Janssen’s Diversity, Equity and Inclusion in Clinical Trials program. This includes trials for investigational medications that treat diseases that disproportionately affect people of color, such as lupus and multiple myeloma.
And increasing the number of people of color in clinical trials is just the beginning, she says. Janssen is examining how clinical trials are designed, the exclusion and inclusion criteria for participants and how clinical trial site staff are engaging with different communities and interacting with people of color. Increasing diversity also involves addressing barriers to enrolling in clinical trials that groups historically excluded sometimes face, Hargraves explains.
“We know the factors and challenges involved in diversifying clinical trials, so it's time to embed these strategies into our day-to-day work to make sure this isn't just a one-off initiative," she says. "This should be the way that we operate, always.”
For an in-depth look at this work in action, we spoke to experts across Johnson & Johnson who are on the front lines of building inclusive clinical trials across four different diseases that have a significant impact on people of color.
A New View of Research on Inflammatory Bowel Disease
Until recently, scientists believed that inflammatory bowel disease (IBD) affected mostly white patients. But more and more, the disease is being diagnosed in people of color, and if that trend continues, the prevalence of IBD—an umbrella term referring to the conditions Crohn’s disease and ulcerative colitis, which cause chronic gastrointestinal tract inflammation—could actually be higher in non-white groups, explains Denise Bronner, Ph.D., Director of Diversity, Equity & Inclusion in Clinical Trials for Janssen’s immunology portfolio. Indeed, between 1970 and 2010, IBD incidence rose 135% in nonwhite patients, compared to only 39% in white IBD patients.
“We must ensure that people of color are being properly represented within clinical research,” she says. “That way, should the therapies that we're studying make it to market, we can better understand how they work within patients who really need them.”
Accomplishing this requires an approach that goes beyond simply recruiting and retaining people of color in IBD clinical trials, Bronner explains. It's essential to also focus on protocol design, impactful educational materials that raise awareness and, most importantly, acutely listen to patients’ needs.
We're hopeful that by collecting imagery from this research, we can generate a catalog of what psoriasis looks like at different stages of the disease across a spectrum of skin tones so that healthcare providers have a more inclusive diagnosis resource where patients can find a picture that looks like them.ShareDid you like reading this story? Click the heart to show your love.
“We’re making sure patients aren't just a data point," says Bronner. "We’re thinking about them and ensuring that they’re truly represented in all aspects of research."
One way Johnson & Johnson is working toward this is through a sponsorship to Color of Crohn's and Chronic Illness (COCCI), the first and only organization that focuses on Black and Brown patients with digestive diseases.
COCCI was founded with a mission to improve the quality of life for BIPOC (Black, Indigenous and People of Color) who are affected by IBD, digestive disorders and associated chronic illnesses through community, research, education and advocacy. Historically, little has been done to bring awareness to and highlight how these diseases have affected communities of color, especially considering the longstanding historical inequity of stomachaches being dismissed when Black and Brown patients have presented them to their providers and to emergency room facilities.
The goal of the sponsorship is to help raise awareness about IBD clinical research while also educating underserved communities about IBD and allowing researchers to meet these patients where they are, helping them to finally feel seen and heard. Informational materials with clear, concise explanations of complex medical terminology will help empower patients to talk to their healthcare providers with confidence. Having physicians who look like these patients at COCCI events will highlight that diversity is not just on the patient side—and provide opportunities for patients to speak about concerns that affect them.
And as Bronner notes, “studies have highlighted that if you have a person of color who serves as an investigator for a study, there's a greater chance that they'll recruit people of color into that study.”
“The sponsorship to COCCI demonstrates our ongoing commitment to understanding the needs and experiences of patients from diverse racial and ethnic backgrounds,” says Jan Wehkamp, M.D., Ph.D., Vice President, Gastroenterology Disease Area Leader for the Immunology Therapeutic Area at Janssen. “We know much more needs to be accomplished, and we continue to strategize and execute DE&I [Diversity, Equity and Inclusion] programs to help achieve health equity for patients living with IBD and other immune-mediated conditions.”
And while changes won't happen overnight, Bronner notes: “We're really moving toward increasing representation above historical numbers. It is up to us to dismantle disparities in our patients’ communities, and it starts with listening to the patient.”
A Dedicated Study for People of Color Living With Plaque Psoriasis
Eight million Americans are living with psoriasis, a chronic inflammatory skin condition, and about 80 to 90% of these patients experience plaque psoriasis, which is characterized by raised, inflamed and scaly patches of skin. In lighter skin tones, the plaques often look red with a silvery white buildup of dead skin cells. On darker skin tones, plaques often appear thicker and darker—purple, gray or dark brown—with less noticeable skin reddening.
It was previously thought that the prevalence of plaque psoriasis was much lower in people of color compared with white patients. This may explain in part why, over the past 20 years, nearly 86% of patients in Phase 3 psoriasis clinical trials have been white. However, the latest epidemiology data suggest the prevalence of psoriasis among people of color is not that much lower. In addition, psoriasis studies have been the least diverse compared to trials for other common dermatology conditions. These factors have created a pressing need to generate additional data to better understand how psoriasis may impact people of color.
Gaps in medical education around the differing appearance of plaque psoriasis and underrepresentation in clinical trials have led to misdiagnosis, delayed diagnosis and limited access to treatment in people of color, explains Andrew Alexis, M.D., M.P.H., Professor of Clinical Dermatology and Vice-Chair for Diversity and Inclusion at Weill Cornell Medicine in New York.
Dr. Alexis is a lead investigator for Janssen's VISIBLE study, a first-of-its-kind clinical study 100% dedicated to Black, Hispanic, Asian, Indigenous and other people of color living with plaque psoriasis. The study is designed to evaluate the efficacy and safety of a treatment in people of color with moderate to severe plaque psoriasis and/or moderate to severe scalp psoriasis to help the medical community better understand the disease’s impact on diverse patient populations.
“By collecting safety, efficacy, biomarker and disease-progression data that are specific to people of color, we can start to help break down the barriers they face,” Dr. Alexis says. “With more information on the disease burden and treatment experience in people of color, we will be better equipped to work with our patients to make the best treatment decisions together, which in turn can help improve health outcomes.”
To raise awareness about the clinical trial, which will launch this summer, Janssen is partnering with community health centers, retail clinics and local organizations to provide disease education and reduce potential obstacles to enrollment. The company also worked with diverse leaders in dermatology to design the study, including training for study investigators and new diagnosis processes.
The VISIBLE study is designed to also generate a collection of clinical photos across varying skin tones that can help advance patient and healthcare provider education on how psoriatic disease presents in people of color and to help healthcare providers better identify plaque psoriasis on darker skin tones.
“We're hopeful that by collecting imagery from this research, we can generate a catalog of what psoriasis looks like at different stages of the disease across a spectrum of skin tones so that healthcare providers have a more inclusive diagnosis resource where patients can find a picture that looks like them,” says Daphne Chan, Ph.D., Head of Medical Affairs at Janssen Dermatology.
Understanding How Lupus Affects Women of Color
The chronic autoimmune disease systemic lupus erythematosus (SLE) is two to three times more common in women of color, who also tend to experience more severe disease and higher mortality rates than white women, says Federico Zazzetti, M.D., Director and Global Medical Affairs Lead for Rheumatology at Janssen.
SLE has many different symptoms, including fatigue, fever and joint swelling, and patients can experience the disease differently, so including people from a range of different racial and ethnic backgrounds in clinical trials is crucial. “By increasing diversity and ensuring proper representation of all these ethnic groups, we are ensuring we understand the safety and efficacy of treatments across different groups of patients,” says Dr. Zazzetti.
Johnson & Johnson has a long-term relationship with the Latin American Group for the Study of Lupus (GLADEL) to better understand how SLE affects Latin American populations. GLADEL is comprised of more than 40 rheumatology research centers with more than 20 years of experience in over 12 Latin American countries—including a cohort of more than 1000 patients representing the broad socioeconomic heterogeneity in the region.
All of these efforts are about educating and building trust with underrepresented groups most affected by multiple myeloma. We’re trying to form relationships with the communities in which these patients live so that when they see our name, they automatically say, ‘OK, we know Johnson & Johnson and we trust them.'ShareDid you like reading this story? Click the heart to show your love.
The initial phase of the relationship explored common barriers to diagnosis and treatment that SLE patients experience, Dr. Zazzetti explains. Now, the second cohort is studying lupus and lupus nephritis associated biomarkers across different disease subtypes to assess how distinct patient populations are impacted.
Collaborating with GLADEL is helping Janssen researchers understand why SLE is more common in certain groups, Dr. Zazzetti says. The study will provide data on the role demographic characteristics and environmental factors contribute to the disease, which he says will help target health inequities and potentially uncover new treatments.
Building Trust With Those Most at Risk for Multiple Myeloma
Multiple myeloma, a cancer of plasma cells, is more than twice as common in African Americans than it is in other races. Yet Black patients are less likely than white patients to be enrolled in clinical trials for the disease. In fact, just 6% of multiple myeloma clinical trial participants are Black.
It's a statistic that Johnson & Johnson is determined to change.
For one, in the upcoming Phase 3 study of a treatment for multiple myeloma, 20% of the participants will be African American, a percentage that's higher than average, explains Jaszianne Tolbert, M.D., Senior Director of Oncology Clinical Development at Janssen. (Notably, the Janssen clinical trial for a different, recently approved treatment for multiple myeloma had 17% representation from African American patients.)
Johnson & Johnson also recently funded an initiative with Mount Sinai Medical Center in New York City to support a multiple myeloma clinical research network with sites across New York, New Jersey and Connecticut. This is important because many clinical trials are located in major cities, which can be challenging to reach for some patients in rural communities. Making site locations more numerous, convenient and accessible may help pave the way toward greater health equity for people living with multiple myeloma. The initiative is also focused on hiring clinical site staff that understand the health hurdles that people of color face.
Also essential when it comes to building trust with people who are considering enrolling in clinical trials: healthcare providers who look like their patients. That's why Janssen has committed to supporting the next generation of diverse doctors and scientists.
For example, the Scholars of Oncology Diversity Engagement Program, which launched last year, aims to build relationships with exceptional ethnically diverse graduate and postdoctoral scientists, helping to shape their careers and increase greater visibility to job opportunities. In 2021 Janssen Oncology also launched the Diversity in Drug Discovery and Development (4D) Fellowship Program in partnership with Drexel University’s Pharmacology and Physiology Department to engage and support under-represented minority students at the graduate level who want to pursue a career in drug discovery and development. And the Scientist Mentoring & Diversity Program (SMDP) Post Doc Program pairs ethnically diverse students who are interested in a career in biotech, consumer health or medtech with industry professionals as mentors. In 2022, Janssen R&D is aiming to hire four postdoctoral fellows from the program.
All of these efforts are "about educating and building trust with underrepresented groups most affected by multiple myeloma," says Dr. Tolbert. "We’re trying to form relationships with the communities in which these patients live so that when they see our name, they automatically say, ‘OK, we know Johnson & Johnson and we trust them.'”