Clinical research in lupus has a mammoth diversity problem: Black individuals are most likely to develop the disease, but they’re the least likely to take part in studies. By the numbers, a 2018 analysis of randomized controlled trials in systemic lupus erythematosus from the years 1997 to 2017 found that 51% of trial participants were White and 14% were Black, even though an estimated 33% of patients with lupus were White and 43% were Black.
Are there ways to fix this disparity? The topic is getting plenty of attention, and speakers at a July 21 online conference touted research projects that aim to boost the numbers of non-White participants in lupus trials.
So far there doesn’t seem to be anything like a magic bullet. Still, the stakes are high. “While race is a social construct, genetic polymorphisms as well as environmental and social differences may influence drugs, safety, and efficacy,” Joy Buie, PhD, MSCR, research director for the Lupus Foundation of America, said at the “Engaging Diverse Participants in Lupus Clinical Trials: The Path Forward” summit held by the American College of Rheumatology (ACR).
As African American patients explained, minority populations often don’t trust the medical system and feel burned by their lengthy struggles to get diagnosed. In some cases, they don’t have full faith in their clinicians and feel unheard.
In a video presentation developed as part of a federal education campaign, Shanelle Gabriel, a poet and musician diagnosed with lupus, described her first reaction when her physician suggested she join a clinical trial. “My first reaction was no. I know my history,” she said, apparently referring to the infamous Tuskegee study that withheld proper treatment from Black men with syphilis for decades. “As an African American woman, I was scared. I didn’t want to be a guinea pig.”
Stacey Kennedy-Conner, a Chicago-area patient and advocate, told the summit audience about how patients can feel that clinical trial information can add “an extra layer of confusion” to their experience. “There’s also the mentality of, ‘If it’s not broke, don’t fix it’: If this medication regimen is working, I don’t want anybody to touch me.”
Monique Gore-Massy, a New York City patient and advocate, added that there can be a perception that patients with lupus “are stuck at home in bed.” In reality, she said, “we have jobs, we have families. Think about that, and consider everything that you’re asking from us: Is this taking me away from my family? Am I going to have to take off work? There may be incentives, but is that worth me taking time off work that I may not get paid for? These are some of the realities that we have to look at in terms of the whole entire clinical trial process.”
It’s also important to keep patients informed of progress being made in trials, she said. “You don’t want to say you just felt like a number and then not get any kind of follow-up.”
In the big picture, “there has to be something that builds up the confidence of individuals so that they are more mindful to participate in these clinical trials,” said Aleta McLean, an Atlanta patient who was diagnosed with lupus 14 years ago.
Several researchers highlighted ongoing projects at the summit. The ACR, for example, has launched a $500,000 initiative called Training to Increase Minority Enrollment in Lupus Clinical Trials with Community Engagement (TIMELY). The federally funded project aims to evaluate whether training of health care professionals can boost clinical trial participation among Black and Hispanic patients.
“We hope to disseminate the results of our project to the scientific community through abstracts, manuscripts, presentations at national meetings,” said rheumatologist Saira Z. Sheikh, MD, of the University of North Carolina at Chapel Hill. “Overall, our goal is to establish new partnerships to support the TIMELY model and advance the education and engagement of providers and community health workers.”
Pamela Payne-Foster, MD, MPH, preventive medicine/public health physician at the University of Alabama College of Community Health Sciences, Tuscaloosa, spoke about the federally funded Deep South Health Equity Project, which is paying patients to take part in an online education program and attend an online regional conference.
Other efforts are underway. The Lupus Research Alliance and its clinical affiliate Lupus Therapeutics have launched two initiatives. One is a program called Project Change (Community-based Health Action Network to Generate Trial Participation and Eliminate Disparities), and the Diversity in Lupus Research Program aims to fund scientists’ work.
Will any of this work boost diversity in clinical trials? As one audience member noted in a Q&A session, health care disparities – and knowledge about them – are nothing new: “Why are we not able to narrow the gap?”
Rear Admiral Richardae Araojo, PharmD, MS, director of the FDA’s Office of Minority Health and Health Equity and associate commissioner for minority health, replied that waves of interest in disparities come and go. “That contributes to why we may not see solutions. But ultimately, there are a lot of people doing a lot of work trying to solve the issues.”
The summit was sponsored by Bristol-Myers Squibb, Genentech, and RemeGen.
A version of this article appeared on Medscape.com.