Study Examines Diversity in Dermatologic Clinical Trials

Dermatologic clinical trials within the United States reflect the growing diversity of the US population, but reporting of both sex and racial/ethnic diversity of research cohorts is still lacking, especially among studies conducted outside of the United States, according to a new report published online by JAMA Dermatology.

Dermatologist Arash Mostaghimi, M.D., M.P.A., M.P.H., of Brigham & Women’s Hospital and Harvard Medical School, Boston, and coauthors analyzed 626 articles reporting randomized clinical trials for acne, psoriasis, atopic dermatitis and eczema, vitiligo, alopecia areata, seborrheic dermatitis and lichen planus because the conditions are common and lack specific racial predilection.

Of the 626 articles, 97 studies were exclusively conducted in the United States and 164 were partially conducted in the United States; 58 of the 97 studies conducted exclusively within the United States reported on the racial and ethnic demographics of study participants.

Among those 58 studies conducted exclusively within the United States that recorded race/ethnicity, 74.4 percent of the 13,681 participants were white. Among these studies, 46 noted racial categories other than white and nonwhite for a total of 11,140 participants, of whom 72 percent where white, 13 percent were African American, 14.7 percent were recorded as Hispanic and 3.3 percent were recorded as Asian.

“While those trials that fully characterized race achieved recruitment of a proportional number of African American participants (compared with the U.S. population at 13 percent), those same trials did not achieve such proportionality with respect to ethnicity,” the study authors write. “Although 17 percent of the population identifies as Hispanic by ethnicity, only 14.7 percent of participants in those same studies identified ethnically as Hispanic. Moreover, the dearth of full reporting of ethnicity and race suggests that the actual racial and ethnic makeup of many studies may be decidedly more homogenous,” according to the article.

Articles about eczema and acne were more likely to include more than 20 percent racially/ethnically diverse participants than psoriasis studies, the authors report.

“Journals and funding sources can reinforce our diverse clinical trial population by continuing to prioritize racial, ethnic, and genetic diversity within the articles they fund and publish; requiring reporting of racial and ethnic data in all dermatology RCTs will lead us even further. These combined efforts will enable dermatology to be an example within medicine for how to best achieve diversity within research and, by extension, clinical practice.”

Editorialists led by Seemal R. Desai, MD, a clinical assistant professor of dermatology at the University of Texas Southwestern Medical Center in Dallas and the founder and medical director of Innovative Dermatology in Dallas, praise the new research. “This work is a welcome specialty-specific addition to the extensive literature documenting the barriers faced when recruiting and maintaining clinical trial patients who are members of minority groups,” they write.  "We hope this article leads to a reexamination of how we can further increase women and minority participants in trials specific to our specialty."