Addressing Racial Disparities in Lupus Clinical Trials

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A new study emphasizes the need to address significant racial disparities in the recruitment and engagement of Black patients with systemic lupus erythematosus (SLE) in clinical trials, finding unique barriers to participation that include mistrust and social determinants of health. The authors of the study, published by Lupus Science & Medicine, suggest that these disparities can be improved through targeted education, increased diversity among clinical trial staff, and culturally sensitive approaches to recruitment and engagement.¹

Lupus occurs when the body's immune system attacks its own tissues and organs, which can impact multiple different body systems, such as the joints, skin, kidneys, blood cells, brain, heart, and lungs. Diagnosis of the disease is challenging because the signs and symptoms are similar to other conditions.²

Investigators noted the importance of the current study, as the incidence of SLE is fivefold to ninefold higher in Black individuals compared to White individuals, with Black patients having an increased risk of developing serious complications from the disease. Further, SLE is the fifth leading cause of mortality among Black women between 15 and 24 years of age and the sixth leading cause of mortality among Black women between 25 and 34 years of age.

“Despite having higher incidence and severity of lupus and worse outcomes as compared with White people, Black people are significantly under-represented in lupus clinical trials. A systematic review of 193 lupus randomised controlled trials (RCTs) conducted from 1997 to 2017 found that Black people were significantly under-represented (14% of RCT participants and 43% of prevalent lupus cases),” the study authors wrote. “Given that response to certain treatments for lupus may vary by race and that cutting-edge treatments should be available to the populations that need them most, urgent action is necessary to increase Black patient participation in lupus clinical trials.”¹

Study Design

The population-based, prospective study, titled Georgians Organized Against Lupus (GOAL), included a cohort of patients with a validated diagnosis of SLE who reside in Atlanta, Georgia. The 2021–2022 GOAL survey included questions that evaluated knowledge, perceptions, and experiences of SLE clinical trials that involved drug therapy. Investigators classified self-reported race as Black or non-Black. The responses to the survey by race were compared using χ² analyses. Among Black individuals included in the survey, factors associated with a willingness to participate in clinical trials were analyzed via univariable logistic regression.

Investigators collected responses from 767 individuals, of whom 80% were Black, 720 were female, and 47 were male.

Study Results

The study authors did not find a significant difference in willingness to participate in clinical trials among Black and non-Black respondents, with 28% of Black individuals willing to participate in lupus clinical trials compared to 31% of non-Black respondents (p=0.071).

The survey found that Black respondents had a decreased likelihood of correctly identifying the definition of a clinical trial (34% vs 70%, p<0.001). Factors found to be indicative of a greater willingness to participate in SLE clinical trials included being of male gender, being unemployed or disabled, having governmental health insurance, and having higher disease activity.

The study authors concluded that future research initiatives should seek to determine other specific factors linked to clinical trial hesitancy among Black patients, such as concerns regarding missing work, transportation, childcare, limited understanding of clinical trial consent forms, and concerns for not receiving adequate treatment for those assigned to receive a placebo.

“Our findings also indicate that further research should be conducted to assess whether clinical trial education, increased racial and gender diversity of trial staff and race-specific and gender-specific trials are effective strategies to increase Black patient recruitment into clinical trials,” the study authors concluded. “Sociodemographic factors (gender, work status, insurance status) and disease-related factors (lupus activity) may also play important roles in clinical trial participation among Black people. Among the subanalysis of male respondents, those with more disease activity and fewer resources appeared to be more willing to participate in clinical trials. More efforts are necessary to educate and provide support to individuals with SLE that are hesitant to participate in clinical trials, especially among under-represented groups including males.”¹

References

1. Williams JN, Mozee H, Bao G, Dunlop-Thomas C, Schofield K, Drenkard C, Lim SS. Racial differences in clinical trial perceptions among a large, predominantly Black cohort of people with systemic lupus erythematosus in the Southeastern USA. Lupus Sci Med. 2025 Jan 4;12(1):e001357. doi: 10.1136/lupus-2024-001357. PMID: 39755584.

2. Mayo Clinic. Lupus. Webpage. Updated October 21, 2022. Accessed January 6, 2025. https://www.mayoclinic.org/diseases-conditions/lupus/symptoms-causes/syc-20365789