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Race reporting and representation in onychomycosis clinical trials: A systematic review

Michelle J Chang1, Yuqing Qiu2,3, Shari R Lipner3

  • 1Drexel University College of Medicine, Philadelphia, PA, USA.

Mycoses
|March 3, 2021
PubMed
Abstract

Insights

Reporting of race and ethnicity in onychomycosis clinical trials is poor, hindering generalizability. Consistent demographic data and subgroup analyses are needed to ensure treatment efficacy is understood across diverse populations.

Area of Science:

  • Dermatology
  • Clinical Trials
  • Health Disparities

Background:

  • Onychomycosis is a prevalent nail condition.
  • Diverse participant inclusion in clinical trials is crucial for generalizable efficacy data.

Purpose of the Study:

  • To systematically review race and ethnicity reporting in onychomycosis clinical trials.
  • To assess representation and treatment outcomes across different demographic groups.

Main Methods:

  • PubMed search conducted in August 2020 for onychomycosis clinical trials.
  • Analysis of primary clinical trial data, excluding post hoc studies.
  • Categorical variables compared using chi-squared and Fisher's exact tests; photos categorized by Fitzpatrick skin type.

Main Results:

  • Only 17.5% of trials reported race/ethnicity data; one trial compared subgroup efficacy.
  • Darker skin tones were rarely depicted.
  • Reporting was associated with topical treatments, US-based sites, industry funding, and post-2000 publications.

Conclusions:

  • Inconsistent reporting of participant demographics limits understanding of treatment efficacy.
  • There is a need for standardized reporting of race and ethnicity in onychomycosis trials.
  • Subgroup analyses are essential for evaluating treatment outcomes in diverse populations.
Keywords:
clinical trialsethnicityfungal nail infectiononychomycosisraceskin of colour

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