Characterizing racial demographics in mycosis fungoides/sezary syndrome clinical trials

Summary: Abstract Body: This study aims to characterize the racial demographics of mycosis fungoides/Sezary syndrome (MF/SS) clinical trials compared to United States (US) census data and explore racial disparities and potential barriers to enrollment. We searched the terms “Mycosis Fungoides/Sezary Syndrome,” “Mycosis Fungoides," “Sezary syndrome,” “CTCL” and “Cutaneous T-Cell Lymphoma” on clinicaltrials.gov. Interventional trials that were completed with results posted and had at least one trial location within the US were included. Of 316 trials initially identified, 27 trials met the inclusion criteria. A total of 1483 patients were characterized, 154 (10%) of which identified as African American (AA)/Black. Compared to population data from the 2023 US Census, AA/Black patients were significantly underrepresented (p < 0.001) in MF/SS clinical trials overall despite 69% of the trial sites occurring in areas with moderate (12.6-49.9%) to high (≥50%) AA/Black populations. Interestingly, substratification revealed that AA/Black patients were significantly overrepresented in phase I clinical trials (p = 0.013) and underrepresented in phase III clinical trials (p < 0.001). This is consistent with trends previously reported in the literature regarding clinical trials at large: AA/Black patients are more likely to be included in early-phase clinical trials evaluating safety yet excluded from later-phase clinical trials evaluating efficacy. The findings of this study reveal significant racial disparities in MF/SS clinical trial enrollment. Identifying these disparities and investigating barriers to enrollment ensures that MF/SS patients of all racial backgrounds are appropriately represented at each phase of the experimental process. Richard Rookwood^{1, 2}, Nicole Schiraldi^{1, 2}, Janet Choi^{1, 2}, Sarah Romanelli^{1, 2}, Megan Darrell^{1, 2}, Rachel Santana Felipes^{1, 2}, David Ciocon^{2, 1} 1. Dermatology, Albert Einstein College of Medicine, New York, NY, United States. 2. Montefiore Medical Center, New York, NY, United States. Minoritized Populations and Health Disparities Research