People of color are persistently underrepresented in global atopic dermatitis (AD) clinical trials, according to a research letter published in the British Journal of Dermatology.
Atopic dermatitis is well studied and known to be prevalent in developed nations; however, limited discussion evaluates the racial and ethnic disparities in global AD clinical trials. Consequently, in this study, researchers assessed enrollment and subgroup analyses of people of racial and ethnic minorities in published phase 2/3 randomized, double-blinded, placebo-controlled trials (RCTs) for AD during the past decade (January 2009-July 2019).
Researchers extracted race and ethnicity data for each RCT according to defined terms from the US Census Bureau. They defined race as an individual’s self-identification with one or more groups (ie, white, black, Asian) whereas ethnicity refers to Hispanic or non-Hispanic origin. Participants were categorized as “other/unspecified” in the event they did not report race or ethnicity. Investigators enrolled a total of 9808 participants in the 33 RCTs that were included in this evaluation. Trial sites included countries from Europe, North America, Asia, and Australia/Oceania. Race and/or ethnicity data was included in 27 RCTs. The participants included whites (54%), Asians, (16.2%) and blacks (8.9%); 2014 (20.5% participants were categorized as “other/unspecified.”
The analyses revealed that of the 811 participants in 9 RCTS held exclusively in Europe, the majority were white (87.7%), Asian (2.6%), and black (1.6%); 8.1% were “other,” and none were Hispanic. Of the 1614 participants in 4 RCTs held exclusively in the US, most participants were white (59.9%), followed by black (28.1%), Asian (6%), American Indian or Alaska Native (1%), Native Hawaiian or other Pacific Islander (0.9%), and “other” (4%); 18.6 % of the participants were Hispanic.
Limitations of the study include incomplete race/ethnicity reporting and race being broadly categorized (white, black, etc.).
The researchers concluded from their findings that racial and ethnic disparities in AD clinical trials limit the generalizability of trial outcomes. “Including trial sites within diverse areas, promoting awareness to patients with skin of color, standardizing race/ethnicity classifications, and including race/ethnicity subanalysis help to encompass global racial and ethnic heterogeneity better,” the researchers suggested.
Price KN, Krase JM, Loh TY, Hsiao JL, Shi VY. Racial and ethnic disparities in global atopic dermatitis clinical trials (published online February 7, 2020). Br J Dermatol. doi:10.1111/bjd.18938