Study offers steps for making SLE trials more inclusive


Black individuals are woefully underrepresented in clinical trials of systemic lupus erythematosus, but a team of researchers have identified several steps to increase the number of Black participants in these trials. It starts with researchers acknowledging and responding to the historical racial bias in healthcare and addressing the deep-seated, racism-related mistrust Blacks have in the health care system, according to a report in Arthritis Care & Research.

“The work to build trust happens long before study recruitment begins,” first author Rodlescia S. Sneed, PhD, MPH, said in an interview. The study calls for stronger relationships between academic centers that conduct the clinical trials and the community providers and institutions that are the SLE patients’ contact with the health care system.

“Academics and rheumatologists must be engaged in the communities where they work beyond the goals of their research projects,” said Dr. Sneed, an assistant professor in the department of family medicine, division of public health, at Michigan State University, Flint.

Dr. Rodlescia S. Sneed

First study of racism in rheumatology

The researchers conducted four separate focus groups in Boston and Chicago made up of Black patients with SLE and their caregivers to better identify barriers to their signing up for clinical trials and what can be done to break them down. A total of 42 individuals participated in the four focus groups.

The study used critical race theory (CRT) to explore how racism leads to underrepresentation of Black patients in SLE clinical trials and to develop strategies to overcome that. Dr. Sneed and colleagues reported that this is the first study in rheumatology to explore the role of racism.

CRT has been the dominant influence on racial scholarship, but its origins are in studying bias in the legal system. CRT hasn’t always been readily applicable to studying public health issues, but in 2010 researchers introduced the Public Health Critical Race Praxis (PHCRP) to adapt the principles of CRT to public health issues.

Dr. Sneed and colleagues used PHCRP to analyze the underrepresentation of Black patients in SLE trials. Previous research has found that Black people make up 43% of all SLE cases but comprise only 14% of SLE trial participants.

Dr. Sneed noted that people with SLE have complex social, psychological, and economic concerns that affect their disease experience. The focus groups revealed that many participants felt that they would derive little personal benefit by participating in clinical trials. Some reported that they feared trial drugs could harm them. Most said they were reluctant to enroll in trials without getting approval from their doctors.

Most participants also said they relied on their own social networks for support – friends, relatives, church members, or lupus support groups. Two participants said they’d been discouraged from signing up for trials by family and friends because of the history of racism in research.

“Research can conflict with those concerns if they are not considered ahead of time,” Dr. Sneed said. “People want to know that you care about them and that you are not just doing the work to make a name for yourself. Showing up consistently over time helps to prove your intentions to the broader community.”

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Addressing racism in medicine head-on

A key takeaway of the study, Dr. Sneed said, is that clinical investigators who want to enroll Black patients with SLE in trials “must reflect on and be prepared to discuss the history of racism in medicine and research. If they don’t feel equipped to discuss this, they should consider consulting with experts well versed in these issues.”

The study identified factors that motivated patients with SLE to sign up for trials. They include recommendations from physicians and reputable institutions, a desire to help the greater good, and culturally sensitive outreach.

“Further,” Dr. Sneed added, “racism in medicine and research is not just historical artifact. It still happens today. Researchers must acknowledge it and discuss their plans to do better.”

Academics and rheumatologists must be engaged in the communities where they work beyond the goals of their research projects.

The study builds on work done in a previous systematic review that found community engagement and ongoing discussions with social network members were crucial for getting underrepresented groups to sign up for clinical trials. Hence the need for stronger ties between academic centers and communities.

“Forming genuine, authentic partnerships with community members is crucial for building trust,” Dr. Sneed said. “The right community partners are credible leaders. They know the history of the community and understand the community's norms and values. People trust those who have been in the trenches for years, advocating for the needs of the community.

“By aligning themselves with community partners, academics can leverage community partners’ social capital in ways that more efficiently and effectively help them to achieve their goals,” she said.

Racism in medicine and research is not just historical artifact. It still happens today. Researchers must acknowledge it and discuss their plans to do better.

Dr. Grace C. Wright
Developing trust with SLE patients and caregivers is an important thread throughout the study, said New York rheumatologist Grace C. Wright, MD, PhD, who is also president of the Association of Women in Rheumatology. “Trust is created in a physician-patient relationship when there is certainty that the relationship is governed by honesty and openness,” she said. “The concordance of race and sex is less relevant when this occurs, but in many cases race/culture/sex concordance may ease the development of trust between physician and patient.”

SLE, Dr. Wright said, is a “glaring example of the discordance between the race of those most severely affected, those included in clinical trials, and those who are the ultimate beneficiaries of the products of these trials.”

Proposing next steps

What’s unique about this study isn’t that it identifies the barriers to Black patients enrolling in SLE trials, which have been amply documented, said Micaela F. Bayard, MD, of Mount Sinai Queens Rheumatology in New York; it’s that it provides a model for overcoming those barriers, namely community-academic partnerships.

“Understanding how we at academic centers can better connect with community physicians and partner with them is really part of a theme we see emerging to getting people in the community to participate in clinical trials,” Dr. Bayard said. “So it’s not just this provider-to-patient partnership; it’s provider-to-provider – really the more academic research–based physician connecting with the community-based physician.”

Dr. Micaela F. Bayard
That also gets to people in underrepresented groups being able to identify with their providers, she said. “This is very important to clinical research as well; not just the person conducting the final research step, but the person who’s doing the recruiting.”

That picks up on the theme of culturally sensitive marketing that Dr. Sneed and colleagues addressed in the study. “I think that includes having people who are already established in the community involved in how they set up marketing of clinical trials and how they decide to target people, whether it’s through churches or health care centers,” Dr. Bayard said.

Dr. Sneed, Dr. Wright, and Dr. Bayard have no relevant financial relationships to disclose.