2 AC&R Study Summaries: Racial Disparities in Lupus Trials & Post-Discharge Follow-Up in Lupus

Racial Disparities in Lupus Clinical Trial Participation

By Saira Z. Sheikh, MD

Why was this study done? Lupus disproportionately affects Black and Latino populations, particularly women in childbearing years. Clinical trials of patients with lupus can advance the development of therapeutics and access to better treatments, as well as improve health outcomes for patients. However, a persistent disparity exists between racial and ethnic patient populations affected most by lupus and those represented in clinical trials. Numerous barriers to engaging patients and providers in clinical trials for lupus have been identified, including a lack of awareness, knowledge or understanding of available trials, trial protocols, eligibility criteria and referral processes.

What were the study methods? The ACR developed an online educational course for healthcare providers involved in the care of patients with lupus to increase knowledge, attitudes, self-efficacy and intentions to refer Black and Latino patients to clinical trials: the Materials to Increase Minority Involvement in Clinical Trials (MIMICT). We used a randomized, two-group, pretest/post-test design to assess the impact of the MIMICT educational intervention on cognitive outcomes theoretically related to behavior change.

What were the key findings? The intervention group had significantly higher post-test scores for knowledge, self-efficacy and intentions to refer Black and Latino patients to clinical trials than the control group. Intervention group participants reported favorable satisfaction with the MIMICT education course, which was strongly and positively correlated with intentions to refer diverse patients to clinical trials at post-test.

What were the main conclusions? The MIMICT education course is an effective resource in addressing provider-side barriers to clinical trial referrals by increasing knowledge about, self-efficacy toward, and intentions to refer Black and Latino patients to clinical trials.

What are the implications for patients? Clinical trials focused on lupus have not been adequately representative of diverse populations, particularly racial and ethnic minorities in the U.S. Black and Latino patients may have more access and opportunities to participate in clinical trials if healthcare providers are better equipped with the knowledge and tools to effectively engage patients in clinical trial discussions so patients can make informed decisions about participation in clinical trials.

What are the implications for clinicians? Healthcare providers act as a critical bridge to connect patients with clinical trial opportunities. Increasing knowledge and awareness about lupus and clinical trial disparities among rheumatologists, primary care providers and subspecialists providing care to patients with lupus, can potentially increase referrals and, ultimately, representation of Black and Latino patients in clinical trials.