Racial Disparities in United States Clinical Trial Enrollment for Mycosis Fungoides and Sézary Syndrome

Racial disparities in clinical trial enrollment can limit the generalizability of therapeutic data, which is particularly damaging for conditions that disproportionately impact minority patients, such as mycosis fungoides and Sézary syndrome.

To characterize the racial demographics of mycosis fungoides/Sezary syndrome (MF/SS) clinical trials and explore potential barriers to enrollment for Black patients in the United States (US).

We searched the terms "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 site within the US were included. We assessed racial demographics, trial enrollment proportions relative to 2023 US Census data, geographic access, exclusion criteria, and race-based reporting practices.

A total of 1483 participants across 27 trials were characterized, 154 (10.4%) of whom identified as Black. Compared to population data from the 2023 US Census, Black patients were significantly underrepresented (P<0.001) in MF/SS trials overall, overrepresented in Phase 1 trials (P=0.013), and underrepresented in Phase 3 trials (P<0.001). Most trial sites (69%) were in areas with moderate (12.6-49.9%) to high (≥50%) Black populations. There were no significant differences in exclusion criteria between low- and high-Black-enrolling trials. Of 36 trial-related publications identified, only 14 (39%) reported participant race.

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.  .