In the past decade, awareness has been raised around improving the equal representation of sex, race, and ethnicity in dermatology research. A recent report published in JAMA Dermatology examined if this awareness has resulted in more inclusion in dermatology trials. The authors performed a systematic literature review to determine if the diversity in trials from 2015-2020 contained more diverse participants than trials in 2010-2015. The findings indicate that while some improvements have been made, much more work in this area is needed.
Background
Clinical trials are crucial steps in determining the safety and efficacy of new therapies for dermatologic conditions. Ideally, the cohort of people studied in these trials would represent the population likely to receive the treatment, but particular racial and ethnic groups are significantly underrepresented in studies. The U.S. Food and Drug Administration has made efforts to broaden eligibility criteria for trial enrollment in an attempt to increase diversity. Still, the problem persists because it is rooted in deeper systemic inequities like socioeconomic instabilities, disparities in care access, and many more.
Some possible barriers to enhancing diversity in dermatology trials include: underrepresented groups are unaware the clinical trials are enrolling; members of racially and ethnically diverse populations lack access to the transportation, means, or time necessary to participate; and the underrepresented communities often have mistrust in the health system and its governing agencies. Recognizing and understanding these barriers is the first of many steps to overcome them.
Study Design and Findings
In a new report published in JAMA Dermatology, researchers examined a total of 392 randomized clinical trials in dermatologic disease areas of alopecia areata, acne, atopic dermatitis, lichen planus, psoriasis, seborrheic dermatitis, and vitiligo. These studies all took place between 2010 and 2015 (n=134) or between 2015 and 2020 (n=192). The authors of the review aimed to determine the overall diversity of the participants in these studies using the definition of “diverse” as consisting of more than 20% of subjects being from nonwhite racial or ethnic groups and having at least 45% female patients.
The authors of this review found that the rate at which the race and ethnicity of clinical trial participants is reported has increased from 59.8% in 2010-2015 to 71.9% in 2015-2020. This means that investigators are being more transparent about the racial and ethnic backgrounds of the patients they study. The actual proportion of studies qualifying as diverse, however, has not improved. The rate of studies examined that included a participant pool qualifying as diverse was 38.14% in 2010-2015 and stayed the same at 38.13% in 2015-2020. The least diverse clinical trials were those investigating psoriasis, with just 12.1% of studies meeting the ethnically diverse standards and 29.5% meeting the standards for gender equality.
Key Takeaway
Despite increased efforts to increase the representation of diverse ethnic groups in dermatology clinical trials, the data show that the inclusion of diverse patient populations is still inadequate. A more diverse population of participants is needed to determine the presentation and therapeutics for all skin diseases adequately; psoriasis studies are particularly non-diverse.
Source:
- https://jamanetwork.com/journals/jamadermatology/article-abstract/2788392
- https://www2.deloitte.com/us/en/insights/industry/life-sciences/lack-of-diversity-clinical-trials.html
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial
