Evaluating participant diversity gaps in atopic dermatitis clinical trials: A systematic review and meta-analysis

Introduction/Objectives: Atopic dermatitis (AD) is a common inflammatory skin condition affecting diverse demographic groups. Clinical trials are crucial for evaluating interventions, but insufficient diversity in age, race, and ethnicity among participants can limit the generalizability of findings. This study aimed to examine the diversity of participants in AD clinical trials based on age, race, ethnicity, and sex.

Methods: We conducted a systematic review and meta-analysis following PRISMA 2020 guidelines. Using the Clinical Trial Diversity Rating (CDR) framework, we evaluated age, race, ethnicity, and sex inclusion in studies published between January 2013 and December 2023.

Results: Our analysis of 17 studies revealed a significant underrepresentation of Asian, Black, and Hispanic/Latinx participants in AD clinical trials, with several studies showing statistically significant disparities. Conversely, white participants were predominantly overrepresented, although this finding was not statistically significant. We also observed disparities in sex representation, with females underrepresented in half of the studies and males overrepresented in the majority. Additionally, our analysis highlighted inconsistent reporting of age, as many studies failed to disclose the intended age range for treatment or the inclusion of participants over the age of 65.

Conclusions: Clinical trials for atopic dermatitis in the United States demonstrated inconsistent reporting of race, ethnicity, and age. Our analysis revealed varying levels of participant inclusion among different demographics, with non-white participants being notably underrepresented in the majority of clinical trials.