Diversity in Dermatology Clinical Trials

Abstract

he growth of the minority population in the United States is outpacing the growth of the non-Hispanic white population. Current projections estimate that the United States will achieve "majority-minority" status in which minority populations total over 50% of the overall population by 2044. 1 This demographic shift has not been reflected in medical research. African Americans, Hispanic individuals, and women are underrepresented in clinical 2 and randomized controlled trials generally, 3 as well as within specific subspecialties including cancer clinical trials, 4 pulmonary research, 5 vascular surgery trials, 6 and orthopedic research. 7 General reporting of the racial and ethnic demographics of study cohorts is uncommon as well, with less than one-third of papers published in high-impact journals across all fields reporting racial or ethnic demographics. 8 Federal efforts have targeted inclusion of clinical trial and research subjects at levels proportionate with those in the US population. 9 The US Food and Drug Administration (FDA) currently requires that all investigational new drug and new drug applications studies include demographic information prior to approval. 10 Additionally, National Institutes of Health (NIH)funded clinical research studies must include women and minorities. 11 Despite a call to action to achieve diversity in research, that we know of there has been no systematic evaluation of clinical and research diversity among dermatology research subjects to date. Hirano et al 12 examined racial representation in atopic dermatitis research, demonstrating that only 60% of clinical trials of eczema and/or atopic dermatitis reported race.This systematic review of the dermatology literature analyzed the degree of racial, ethnic, and sex representation in recent randomized clinical trials (RCTs) for acne, psoriasis, atopic dermatitis and eczema, vitiligo, alopecia areata, seborrheic dermatitis, and lichen planus (LP). These conditions were selected because they are: IMPORTANCE Though there have been significant shifts in US demographic data over the past 50 years, research cohorts lack full racial and ethnic representation. There is little data available regarding the diversity of dermatology research cohorts with respect to sex, race, and ethnicity.OBJECTIVE To characterize and assess the representation of racial and ethnic minorities and women in randomized controlled trials across a range of dermatologic conditions.EVIDENCE REVIEW All randomized clinical trials (RCTs) were identified between July 2010 and July 2015 within the PubMed database using the following keywords: "psoriasis," "atopic dermatitis," "acne," "vitiligo," "seborrheic dermatitis," "alopecia areata," and "lichen planus." Diverse study populations were defined as including a greater than 20% racial or ethnic minority participants based on US census data. The distributions of sex and race groups in studies were compared by journal type, disease type, and funding source.FINDINGS Of the 626 articles reporting RCTs included in this ...

Atopic dermatitis in diverse racial and ethnic groups—Variations in epidemiology, genetics, clinical presentation and treatment

“…Despite the high prevalence of AD in skin of colour populations, there is little data on the efficacy of common therapies for AD in non‐White ethnic groups. This is, at least in part, due to underrepresentation of some races in clinical trials as well as lack of subset analyses by race . Of AD clinical trials published between 2000 and 2009, only 59.5% of studies included race and ethnicity as baseline demographic information .…”

Psoriasis in Patients of Color: Differences in Morphology, Clinical Presentation, and Treatment

“…For clinicians, more attention on the differences would help make earlier diagnoses, personalize physician-patient conversations, and advocate for further education on this issue in residency training programs. Potentially greater impact on QOL with scalp psoriasis 2,5,a Greater BSA involvement in Asian patients 6 More severe disease at presentation 7,a Treatment Preference for foams and lotions for scalp 2,a UV consideration for prevention of hyperpigmentation 8 No known differences in efficacy of systemic treatments 5 Patients with skin of color underrepresented in clinical trials 9 Reduced patient recognition of certain treatments 10 Psychosocial impact Higher DLQI at baseline 6,a Abbreviations: QOL, quality of life; BSA, body surface area; DLQI, dermatology life quality index.…”

Reporting Quality of Randomized Controlled Trials for the Treatment of Eczema with Chinese Patent Medicine Based on the CONSORT‐CHM Formulas 2017

“…It is more likely to report favorable outcomes for industry-sponsored studies [ 31 ]. In our study, only 6.25% of the trials reported the funding source, whereas nearly 70% of dermatology RCTs from PubMed database described the funding source [ 32 ].…”