Background: Lupus disproportionately affects racially and ethnically diverse populations, [1] yet there is a significant disparity between those affected and those enrolled in clinical trials. Systemic lupus erythematosus (SLE, or “lupus”) is a chronic, inflammatory autoimmune disease that disproportionately affects diverse racial and ethnic populations, [1] yet there is a significant disparity between those affected by lupus and those enrolled in lupus clinical trials [2]. Improving representation in and access to lupus clinical trials is critical to ensure equity in the process, products, and benefits of clinical research and resulting therapeutic advancements [3].

Objectives: The objective of the present work is to characterize the perspectives, preferences, and unmet needs of community collaborators to strengthen participation of underrepresented groups in lupus clinical trials and describe barriers, facilitators, and tangible solutions at the individual, interpersonal, organizational, and systems level to advance equity in lupus clinical trials.

Methods: Five Community Feedback Sessions were held between January and August 2024 over Zoom with individuals from four community collaborator groups: 1) clinician-investigators, and 2) research staff from prominent academic lupus clinical trial centers in North America; 3) individuals living with lupus; and 4) representatives from relevant industry and patient advocacy organizations. Each feedback session was held with participants from one of the key community collaborator groups. Feedback sessions were led by trained facilitators utilizing discussion guides developed to gather actionable feedback on challenges, facilitators, and strategies for recruiting and enrolling racial and ethnic minority patients into lupus clinical trials. These sessions were recorded, and feedback was summarized to explore key takeaways and recommendations from community collaborators. Descriptive statistics were used to summarize interest form and evaluation survey responses.

Results: Thirty-one community collaborators participated in the feedback sessions, representing clinician-investigators (n=9), research staff (n=8), patients with lupus (n=9), and organizational representatives (n=5). Key barriers to improving participation of underrepresented groups in lupus clinical trials included socioeconomic factors and logistical challenges, such as trial commitment burden, transportation access, inadequate compensation, visit time, the cost of missing work, and language accessibility. Session participants emphasized the critical need for ongoing education for both providers and patients to facilitate better communication regarding clinical trials within and between clinical professionals, patients, and communities. Community engagement was frequently highlighted throughout the feedback sessions as a key facilitator in promoting enrollment of underrepresented individuals in clinical trials. Building long-term relationships with patients and involving trusted messengers (e.g., primary care providers, community health workers, and lupus support groups) were emphasized as critical solutions to addressing historical and current issues around mistrust in research and medicine. Session participants identified opportunities for patient engagement, ongoing education, and health literate and culturally considerate resources developed in partnership with community members, to improve communication about clinical trials. Following participation, attendees were sent an evaluation survey in which 18 of 19 respondents (94.7%) stated that they definitely would participate in a feedback session again.

Conclusion: To address the underrepresentation of diverse populations in lupus clinical trials, a comprehensive, multifaceted approach is essential. Involving the entire clinical trial team, along with patient, organizational, and other community partners, can help develop culturally- and contextually-relevant strategies to improve equity in lupus clinical trial access and participation. Each community collaborator group offered unique as well as converging perspectives on unmet needs and solutions to improve lupus clinical trials, including improved incentives and accommodations for trial participants, systems to support trial access, and expanded and sustained engagement between researchers and communities. Findings illustrate how the community feedback session model can be utilized to gather feedback that is likely to be relevant, useful, and adopted in research and practice, ultimately improving the potential scalability, sustainability, and impact of this approach.

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[2] Falasinnu T, Chaichian Y, Bass MB, Simard JF. The Representation of Gender and Race/Ethnic Groups in Randomized Clinical Trials of Individuals with Systemic Lupus Erythematosus. Curr Rheumatol Rep. 2018;20(4):20. Epub 20180317. doi: 10.1007/s11926-018-0728-2.

[3] Sheikh SZ, Englund, TR, Burriss SW, Bull J, Harry A, Groark JG, Hall AM, Miller M, Roth DA. EMBRACE: One Small Story in Lupus—One Giant Challenge in Clinical Trials. ACR Open Rheumatology. 2022; 4: 747-752. https://doi.org/10.1002/acr2.11477 .

Acknowledgements: This project was supported by the Food and Drug Administration (FDA) Office of Minority Health and Health Equity of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $874,999, with 100 percent funded by FDA OMHHE/HHS (1U01FD007781-01; 3U01FD007781-01S1). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government. This project was also supported by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, through Grant Award Number UM1TR004406. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Disclosure of Interests: Tessa Englund: None declared, Claire Timon: None declared, Katherine Holben: None declared, Saira Sheikh GlaxoSmithKline, AstraZeneca, Biogen, Cabaletta Bio, Aurinia Pharmaceuticals.

© The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license ( http://creativecommons.org/licenses/by-nc-nd/4.0/ ). Neither EULAR nor the publisher make any representation as to the accuracy of the content. The authors are solely responsible for the content in their abstract including accuracy of the facts, statements, results, conclusion, citing resources etc.