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Background: In the United States (US), lupus has a disproportionate impact on racially and ethnically minoritized groups and other individuals from disadvantaged backgrounds. This burden underscores the importance of ensuring diverse representation in clinical trials to advance equitable access to innovative therapies for lupus. Medicaid is a public insurance program that provides health insurance coverage to more than 80 million low-income, disabled, and other vulnerable individuals and families in the US [1, 2]. In January 2022, Medicaid coverage was expanded to include the “routine costs” associated with clinical trial participation [3]. However, the expanded coverage of trial participation in Medicaid does not include investigational items, services that are not typically covered outside the trial, and services that are solely for data collection [3]. Medicaid insurance may present significant barriers to both recruitment and retention in lupus clinical trials, with enrollees facing financial, logistical, and informational challenges not covered through government policies.
Objectives: This study explores how Medicaid coverage is associated with the recruitment and retention of lupus clinical trial participants by examining reported barriers encountered at clinical trial sites.
Methods: This cross-sectional study utilized data reported by investigators and research staff (site representatives) from a survey of established lupus clinical trial sites across the US between March and July 2022. Survey measures included questions to assess site-level barriers to clinical trial participation, recruitment and retention practices and barriers, and reported demographic characteristics of trial participants (e.g., insurance status). Descriptive statistics were used to explore associations between site-reported patient Medicaid coverage with reported barriers to lupus clinical trial participation. Clinical trial sites were categorized into two groups for comparison based on the national reported percentage of patients with Medicaid insurance [1]: 1) sites serving patient populations with Medicaid insurance below (<18.9%); or 2) above the national average (>18.9%).
Results: Among the 46 US lupus clinical trial sites, 82.6% (n=38) reported Medicaid insurance among patients with lupus served at their institutions and were included in the analysis. Nearly two-thirds (65.7%) of sites reported higher proportions of Medicaid insurance among their lupus patient populations as compared to the national average, and 34.2% of sites reported serving a lower proportion of Medicaid-insured patients than the national average. Sites with a higher proportion of patients on Medicaid reported patient financial concerns as a barrier to trial recruitment more frequently than sites with lower proportions of Medicaid-insured patients (36% vs 7.7%, respectively). Additionally, loss to follow-up was more frequently reported as a retention challenge among sites with higher proportions of Medicaid-insured patient populations than sites with lower proportions of Medicaid-insured patients (20% and 7.6%, respectively). Nearly half (48%) of sites serving a higher proportion of patients on Medicaid reported that financial incentives were an effective clinical trial recruitment strategy, as compared to 30.7% of sites serving a lower proportion of Medicaid-insured patients than the national average.
Conclusion: Despite expansion of US public insurance programs to include the routine costs of clinical trial participation for Medicaid enrollees, barriers to participation in lupus clinical trials are still frequently reported among lupus clinical trial sites. Understanding the different challenges and needs of clinical trial sites serving a greater proportion of low-income patients is critical to informing tangible solutions and practical policies that improve clinical trial access among individuals from disadvantaged backgrounds. Addressing these socioeconomic and logistical barriers, such as transportation, childcare, and financial considerations, is essential for improving recruitment, retention, and ensuring equitable participation in lupus clinical trials.
REFERENCES: [1] US Census Bureau. Health Insurance Coverage in the United States: 2023. Published September 10, 2024. Available from:
[2] Donohue et al. The US Medicaid Program: Coverage, Financing, Reforms, and Implications for Health Equity. JAMA. 2022;328(11):1085-1099. doi: 10.1001/jama.2022.14791.
[3] Takvorian et al. A hidden opportunity—Medicaid’s Role in Supporting Equitable Access to Clinical Trials. New England Journal of Medicine. 2021; 384(21). doi: 10.1056/NEJMp2101627.
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.
Disclosure of Interests: Harish Pandyaram: None declared, Claire Timon: None declared, Saira Sheikh GlaxoSmithKline, AstraZeneca, Biogen, Cabaletta Bio, Aurinia Pharmaceuticals, Tessa Englund: None declared.
© The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license (