Increasing Ancestral Diversity in Systemic Lupus Erythematosus Clinical Studies

Abstract

Non-White people are more likely to develop systemic lupus erythematosus (SLE) yet are underrepresented in SLE clinical trials. The efficacy and safety of drugs may be influenced by ancestry, and ancestrally diverse study populations are necessary to optimize treatments across the full spectrum of patients. However, barriers to entry into clinical trials are amplified in non-White populations. To address these issues, a conference was held in Bethesda, Maryland, from October 15-16, 2019, entitled "Increasing Ancestral Diversity in Systemic Lupus Erythematosus Clinical Studies: Overcoming the Barriers." Conference participants included people with lupus, lupus physicians, lupus clinical trialists, treatment developers from biotechnology, social scientists, patient advocacy groups, and US government representatives (The Office of Minority Health, Centers for Disease Control and Prevention, National Institutes of Health, and the Food and Drug Administration). For all these groups, the organizers of the conference purposefully included people of non-White ancestry. Decreased participation of non-White SLE patients in clinical research was evaluated through historical, societal, experiential, and pragmatic perspectives, and several interventional programs to increase non-White patient participation in SLE and non-SLE research were described and discussed. The presentations and discussions highlighted the need for changes at the societal, institutional, research team, referring physician, and patient education levels to achieve equitable ancestral representation in SLE clinical studies.

The association of lupus nephritis with adverse pregnancy outcomes among women with lupus in North America

“…26,27 A strength of this study is the high proportion of Black pregnant women with SLE, a group that is often under-represented in clinical research. 21,28…”

“…26,27 A strength of this study is the high proportion of Black pregnant women with SLE, a group that is often under-represented in clinical research. 21,28 Few studies have evaluated racial disparities in pregnancy outcomes among women with SLE and LN. The LUMINA study, a multiethnic study of patients with SLE, revealed a 5-fold odd of adverse pregnancy outcomes in women with kidney involvement prior to pregnancy.…”

“There’s so much to be done”: a qualitative study to elucidate research priorities in childhood-onset systemic lupus erythematosus

“…To address the lack of adequate representation of racial minority groups in SLE research, a 2019 conference among patients with SLE, SLE physicians, clinical trialists, treatment developers from biotechnology, social scientists, patient advocacy groups and US government representatives explored solutions for increasing diversity in SLE research studies. 19 Best practices for clinicians and researchers were developed, which included reflecting on how personal and institutional culture lead to racial bias in research questions and study design, the need to avoid making assumptions about the ‘kind’ of patient who would participate in a trial, and increasing recruitment of under-represented minorities to the field of rheumatology. Experts in our study expressed several opportunities to address these issues, including having a diverse research staff, including outcomes that are important to patients and utility of funding for patient navigators ( box 1 ).…”

Use of Popular Opinion Leader Models to Disseminate Information About Clinical Trials to Black Individuals With Lupus in Two US Cities

“…The principle of justice highlighted in the Belmont Report calls for equitable distribution of the benefits and risks of participating in research across the populations affected by a disease (8). While race is a social rather than biological construct, genetic polymorphisms that vary by ancestry can influence a drug's safety and efficacy (9,10). More balanced representation of racial and ethnic groups in clinical research is imperative to achieving health equity.

Through community–academic partnerships in Boston and Chicago, we developed a now freely accessible curriculum to promote better understanding of clinical trials, acknowledging the history of racism in medical research and barriers and facilitators of participation. We utilized a popular opinion leader (POL) model to recruit and train leaders from predominantly Black communities to disseminate information through their social networks and communities.

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“…The principle of justice highlighted in the Belmont Report calls for equitable distribution of the benefits and risks of participating in research across the populations affected by a disease ( 8 ). While race is a social rather than biological construct, genetic polymorphisms that vary by ancestry can influence a drug's safety and efficacy ( 9 , 10 ). More balanced representation of racial and ethnic groups in clinical research is imperative to achieving health equity.…”