Skin phototype diversity and representation in melanoma clinical trials from 2000 to 2023: A systematic review

Summary: Abstract Body: Although melanoma incidence is lower in skin of color (SOC) than in White patients, the prognosis in SOC is worse. This is often attributed to later stages of presentation in SOC compared to White patients, but even when matched for stage, survival in White patients remains significantly better. Despite the rapid proliferation of melanoma clinical trials, adequate SOC representation remains to be determined. This study aims to characterize the diversity of skin phototypes and their representation in melanoma clinical trials from 2000 to 2023. The PubMed, Embase, Web of Science, and Cochrane Central Register of Controlled Trials databases were searched from January 1, 2000, to December 31, 2023. Articles were included if they were randomized controlled trials (RCTs) in melanoma patients with published original results. Articles were excluded if they were study protocols, abstracts, conference proceedings, updates or subsequent analyses of existing RCTs, contained non-human subjects, or were not written in English. The database searches resulted in 5,766 citations, of which 367 were ultimately included. On average, 41.5% of participants were female, and only one article reported Fitzpatrick skin type (I-III) in the patient demographics. Only 21.8% (n= 80) of articles reported race, with representation limited in diversity and number; for instance, among the 33 studies that included Black patients, they comprised just 1.1% of the total patient population on average. When reported, other races had similar poor representation, with averages of 2.0% for Asian, 1.8% for Hispanic, 0.3% for American Indian/Native Alaskan, and 2.3% for Other. There is poor skin phototype diversity and representation of racial and ethnic minorities in melanoma RCTs from 2000 to 2023. Additional work is needed to help reduce health disparities in melanoma therapies. Sabah Choudhury^{1, 2}, Aneri Parekh^{1, 2}, Viviana Flores^{1, 2}, Eric Xia^{1, 2}, Dilshad Sachedina^{1, 2}, David Flynn¹, Debjani Sahni^{1, 2} 1. Boston University Chobanian & Avedisian School of Medicine, Boston, MA, United States. 2. Dermatology, Boston Medical Center, Boston, MA, United States. Pigmentation, Melanoma, and Melanoma Immune Surveillance