Deparment of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.
NYU Grossman School of Medicine, New York, NY, USA.
J Dermatolog Treat. 2022 Dec;33(8):3086-3097. doi: 10.1080/09546634.2022.2114783. Epub 2022 Aug 31.
An increasing body of literature describes underreporting of race and ethnicity, and overrepresentation of White individuals in clinical trials. We aimed to evaluate the racial and ethnic diversity of US participants in clinical trials for acne, atopic dermatitis (AD), and psoriasis. We performed a comprehensive review of clinical trials for these common dermatologic diseases that were published between January 2014 and July 2019. Race and ethnicity reporting among all trials, and the racial and ethnic distribution of US participants were compared by skin disease, intervention type, and trial phase. In total, 103 articles representing 119 unique trials were evaluated. Race and ethnicity were reported in only 22.7% of trials. The proportion of White participants (77.5%) was higher than that of the US population (72.5%, < .01); a finding largely driven by psoriasis trials (84.7% White). The proportions of non-White and Hispanic individuals in non-topical (21.0 and 16.3%, respectively) and Phase III (20.5 and 18.7%, respectively) trials were lower than those in topical (23.5 and 23.3%, respectively; < .01) and Phase I/II trials (25.6 and 22.3%, respectively; < .01). Race and ethnicity remain underreported in dermatologic clinical trials, and US trial participant diversity differs by skin disease, intervention type, and trial phase.
越来越多的文献描述了种族和民族报告的不足,以及临床试验中白种人代表性过高的问题。我们旨在评估美国参与者在痤疮、特应性皮炎 (AD) 和银屑病临床试验中的种族和民族多样性。我们对 2014 年 1 月至 2019 年 7 月期间发表的这些常见皮肤病的临床试验进行了全面综述。通过皮肤病、干预类型和试验阶段比较了所有试验中的种族和民族报告情况,以及美国参与者的种族和民族分布情况。共评估了 103 篇文章,代表 119 项独特的试验。只有 22.7%的试验报告了种族和民族情况。白种人参与者(77.5%)的比例高于美国人口(72.5%,<.01);这一发现主要是由银屑病试验(84.7%为白种人)驱动的。非局部(分别为 21.0%和 16.3%)和 III 期(分别为 20.5%和 18.7%)试验中非白人和西班牙裔个体的比例低于局部(分别为 23.5%和 23.3%,<.01)和 I/II 期试验(分别为 25.6%和 22.3%,<.01)。皮肤病学临床试验中种族和民族报告仍然不足,美国试验参与者的多样性因皮肤病、干预类型和试验阶段而异。