Background/Purpose: Systemic lupus erythematosus disproportionately affects Black/African American (AA) and Latino/a populations.¹ Challenges to engage and include these populations in clinical trials (CTs) can be grouped into patient-side barriers to participation and provider-side barriers to referring patients.¹ Our aim was to address barriers in engaging with racial/ethnic populations and potential ways to ensure representation in lupus CTs.

Methods: In-depth qualitative interviews were conducted with lupus patients from underrepresented populations (Black/AA, Latino/a, Native American, Asian/Pacific Islander) and physicians (investigators or referring physicians in dermatology or rheumatology). Participants were screened to fulfill demographic quotas and assess conflicts of interest; those who qualified provided consent to be interviewed and were compensated for their participation. Interviews followed a semi-structured format in which participants were asked open-ended questions about CT awareness and motivating factors/barriers for CT participation.

Results: A total of 33 patients and 20 physicians participated in the study. Patient characteristics varied by age, region, education, employment status and type/severity of lupus (Table 1); physicians had varied practice settings and work experience (Table 2). The primary barrier to CT participation reported by patients was concern for investigational drug safety/efficacy (Figure 1). This included potential side effects, unknown efficacy and risk of missed benefit with placebo. Patients also reported impact of CT burden, such as time, transportation and financial impact of visits. Fewer patients reported mistrust of the healthcare system as a barrier; historical factors such as mistreatment of underrepresented groups were less impactful than day-to-day challenges. Patients noted that participation could be improved by highlighting the value of CTs to individuals and their communities in a culturally competent way, minimizing trial burden and increasing trust through personal recommendation from treating physicians. From the physician perspective, < 50% were aware of ongoing CTs locally and some reported insufficient information for referring patients appropriately. Unconscious/implicit bias, such as assuming patients will not want to participate or be adherent, was also reported to influence physicians. Providing physicians with a centralized CT information source (website) and networking support, building patient awareness through trusted sources (churches, community centers) and including a broader mix of investigators from underrepresented communities may remove these perceived barriers.

Conclusion: Increasing participation of underrepresented racial/ethnic groups in lupus CTs is essential for assessing drug safety and efficacy, especially when these populations are most affected by the disease. Patient education, reduced CT burden, physician awareness of available CTs and strategies and educational efforts to address potential implicit bias should be critical components of health equity efforts.

1. Sheikh. J Clin Med. 2019;8:1245.

Biogen sponsored the study and provided funding for medical writing support.

Figure 1. Patient-Reported Drivers and Barriers to Lupus Clinical Trial Participation Among Underrepresented Racial and Ethnic Groups

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/increasing-participation-of-underrepresented-groups-in-lupus-clinical-trials-insights-from-qualitative-interviews-with-patients-and-physicians/