Ethnoracial representation in hidradenitis suppurativa clinical trials

Abstract

Background: Hidradenitis suppurativa (HS) is an inflammatory skin disorder characterized by recurring painful and suppurating lesions, with the disease disproportionately affecting black populations in the United States. Ethnoracial representation in clinical trials is vital to ensuring results are generalizable. The purpose of this study is to examine whether ethnic or racial disparities exist in HS clinical trials.

Methods: The US National Library of Medicine clinical trials database (clinicaltrials.gov) was queried to identify HS clinical trials. Trials that did not present ethnic or racial data on either the website or publication were not considered.

Results: A total of 57 HS trials were identified. Of these, 23 trials, containing 2530 patients, included racial or ethnic data (Table 1). White patients made up 76.1% (1435/1886) of the study population, followed by Blacks or African Americans (13.7% (238/1732)), Hispanics or Latinos (7.2% (20/279), Asians (2.6% (26/1016)), American Indians or Alaska Natives (1.3% (14/1051)), and Native Hawaiians or Other Pacific Islanders (0.4% (4/926)).

Discussion: Our results establish a significant lack of minority ethnoracial representation in HS clinical trials. Since HS prevalence is highest among Blacks or African Americans, it is imperative that future clinical trials are conducted with a larger proportion of this population. Furthermore, clinical trials that did not report racial or ethnic information were conducted in countries with predominantly White populations, which likely skewed the results of this study and caused underreporting of these patients.

Keywords: Clinical trials; Diversity; Hidradenitis suppurativa; Inflammation; Inflammatory conditions.