Racial and ethnic representation across acral lentiginous melanoma clinical trials

Acral lentiginous melanoma (ALM) is a rare form of cutaneous melanoma (CM) affecting the palms, soles and nailbeds. ALM predominantly affects people with skin of color, and it is the most common form of CM diagnosed in Black populations. Globally, ALM is the predominant CM subtype diagnosed in certain Asian and Latin American countries. Thus, it is imperative that ALM clinical trials reflect the diversity of participants affected. The purpose of this study is to assess racial and ethnic representation in Phase I-IV clinical trials for ALM using The U.S. National Library of Medicine clinical trials database and PubMed. 14 clinical trials with 442 participants were included in our analysis. 11 clinical trials included other melanoma subtypes, as 38.5% of participants were diagnosed with ALM, 37.4% with mucosal melanoma, and 24% with other subtypes or skin conditions. Eight clinical trials conducted globally reported race and ethnicity, and we found that 61.7% of the participants were White, 30.7% were Asian, 3.1% were Black, and 0.4% were reported as more than one race. Five studies reported ethnicity, in which only 7.6% of participants were Hispanic. Comparing racial and ethnic representation for clinical trials in the U.S. that reported race and ethnicity to the U.S. Census Bureau and a previously published Surveillance, Epidemiology, and End Results study, White participants were highly represented, and racial and ethnic minority participants were underrepresented. Our findings highlight the need for the systematic inclusion of racial and ethnic minority groups and improved demographic reporting in ALM clinical trials.