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Reporting of Racial and Ethnic Diversity in Dermatology Clinical Trials Involving Canada, 2020 to 2025: A Systematic
Hiba Elhaj1, Amina Moustaqim-Barrette1, Sarah Aly1
1Faculty of Medicine, McGill University, Montreal, QC, Canada.
Abstract:
Randomized clinical trials (RCTs) guide dermatologic care, yet reporting of participant race, ethnicity, and skin type is inconsistent. Post-2020 initiatives aimed to improve equity, but contemporary Canadian dermatology trials have not been systematically evaluated. This review assessed the frequency, quality, and consistency of race, ethnicity, and Fitzpatrick skin-type reporting in dermatology RCTs involving Canadian participants and compared representation with Canadian population demographics. Phase 2 to 4 dermatology RCTs including Canadian participants published between January 2020 and July 2025 were identified via PubMed and ClinicalTrials.gov using disease-specific terms. Trial characteristics, demographic reporting, and analytic use of race, ethnicity, and skin type were extracted. Demographics were standardized to 2021 Canadian Census categories. Analyses were performed at the trial level due to limited site-specific enrollment data. Ninety-nine RCTs (36 178 participants) were included; most studied psoriasis (44%) or eczema (41%) and were industry-funded (98%). Race was reported in 93% of trials, ethnicity in 39%, and Fitzpatrick skin type in 10%. Detailed racial or ethnic categories appeared in 37% of trials, and only 1% aligned with Census categories. Seven percent used demographic data in analyses. Across aggregate multinational enrollment, visible minority representation approximated national benchmarks (23% vs 26.5%), while Indigenous participants were markedly underrepresented (0.2%). Multinational designs and limitations in site-level reporting restrict precise assessment of Canadian enrollment. Race reporting in Canadian dermatology RCTs is now routine, but diverse enrollment and analytic use of demographic data remain limited. Standardized reporting, site-level enrollment data, and culturally appropriate recruitment are needed to improve representation and ensure findings reflect Canada's diverse population.
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