INTRODUCTION
Retrospective analyses of clinical trial research over the last two decades have revealed that minority enrollment is lacking across all medical specialties, and efforts to increase representation have historically been limited.1,2 Moreover, prior studies have suggested that Black patients are disproportionately over-enrolled in early-phase clinical trials assessing safety and underenrolled in later-phase trials that evaluate efficacy, limiting their access to potentially life-saving treatments and contributing to persistent disparities in clinical outcomes.2
A lack of equitable inclusion of racial and ethnic minorities in clinical trial research is particularly relevant for conditions like mycosis fungoides (MF) and Sézary syndrome (SS), where significant racial disparities exist in disease incidence, presentation, and outcome. According to Surveillance, Epidemiology, and End Results (SEER) data from 2000 to 2018, the incidence ratios of MF and SS are higher in Black individuals compared to their White counterparts (6.50 and 4.92 vs 0.45 and 0.17, respectively).3 Black patients are also diagnosed at an earlier age and more advanced stage, experience greater total body surface area involvement, face a higher risk of secondary complications, and have significantly poorer survival outcomes, even after adjusting for disease characteristics, socioeconomic factors, and treatment modalities.4-8
Previous studies have sought to characterize racial and ethnic participation in CTCL clinical trial research, however they utilized median percentages across trials to evaluate representation, did not analyze potential barriers to enrollment, or excluded Phase 1 clinical trials from their analyses.9,10 The aim of our study was
A lack of equitable inclusion of racial and ethnic minorities in clinical trial research is particularly relevant for conditions like mycosis fungoides (MF) and Sézary syndrome (SS), where significant racial disparities exist in disease incidence, presentation, and outcome. According to Surveillance, Epidemiology, and End Results (SEER) data from 2000 to 2018, the incidence ratios of MF and SS are higher in Black individuals compared to their White counterparts (6.50 and 4.92 vs 0.45 and 0.17, respectively).3 Black patients are also diagnosed at an earlier age and more advanced stage, experience greater total body surface area involvement, face a higher risk of secondary complications, and have significantly poorer survival outcomes, even after adjusting for disease characteristics, socioeconomic factors, and treatment modalities.4-8
Previous studies have sought to characterize racial and ethnic participation in CTCL clinical trial research, however they utilized median percentages across trials to evaluate representation, did not analyze potential barriers to enrollment, or excluded Phase 1 clinical trials from their analyses.9,10 The aim of our study was
