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Racial representation in clinical trials for dermatological new molecular entities
1Department of Dermatology, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Clinical and Experimental Dermatology
|August 4, 2021
Summary
Black individuals are under-represented in dermatology clinical trials for new treatments. This inequitable participation affects access to novel therapies and highlights the need for better minority inclusion in dermatological research.
Area of Science:
- Dermatology
- Clinical Research
- Health Equity
Background:
- Ethnic minorities face unequal access to dermatological treatments.
- Under-representation in clinical trials limits understanding of treatment efficacy across diverse populations.
Purpose of the Study:
- To assess the representation of black individuals in US Food and Drug Administration (FDA)-approved dermatological new molecular entity (NME) clinical trials since 2015.
- To identify potential disparities in clinical trial participation for key dermatological conditions.
Main Methods:
- Analysis of data from the FDA Drug Trials Snapshots program.
- Inclusion criteria focused on NMEs approved from January 2015 to the present.
- Examination of participant demographics, specifically focusing on black individuals.
Main Results:
- Significant under-representation of black participants was observed in trials for acne vulgaris NMEs.
- Black individuals were also under-represented in clinical trials for new treatments for plaque psoriasis.
- Inequitable participation was noted in trials for actinic keratosis and squamous cell carcinoma NMEs.
Conclusions:
- Clinical trials for dermatological NMEs show a persistent under-representation of black participants.
- Addressing ethnic minority under-representation is crucial for advancing dermatological practice.
- Prioritizing diversity in clinical research will improve health outcomes for minority populations.
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