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皮肤科临床试验的多样性:一项系统评价

Diversity in Dermatology Clinical Trials: A Systematic Review.

作者信息

Charrow Alexandra, Xia Fan Di, Joyce Cara, Mostaghimi Arash

机构信息

Harvard Combined Dermatology Residency Training Program, Harvard Medical School, Boston, Massachusetts.

Brigham & Women's Hospital, Harvard Medical School, Boston, Massachusetts.

出版信息

JAMA Dermatol. 2017 Feb 1;153(2):193-198. doi: 10.1001/jamadermatol.2016.4129.

DOI:10.1001/jamadermatol.2016.4129
PMID:28055072
Abstract

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 analysis, 532 (85.0%) reported the sex of study participants. Overall, 52 of 626 international (11.3%) studies and 58 of 97 studies (59.8%) conducted exclusively within the United States reported on the racial or ethnic demographics of study participants. Across all RCTs exclusively recruited within the United States that reported race, 74.4% of study participants were white. Disease type was significantly associated with the degree of racial diversity (P < .001) within a study cohort: 30.0% of US-based psoriasis had more than 20% racially or ethnically diverse research participants as compared with 73.9% of acne studies and 91.7% of eczema studies.

CONCLUSION AND RELEVANCE

Dermatologic clinical trials within the United States reflect the growing diversity of the US population. Reporting of both sex and racial/ethnic diversity of research cohorts is still lacking, especially among studies conducted outside of the United States.

摘要

重要性

尽管在过去50年里美国人口数据发生了显著变化,但研究队列缺乏完整的种族和族裔代表性。关于皮肤病学研究队列在性别、种族和族裔方面的多样性,可用数据很少。

目的

描述和评估一系列皮肤病状况的随机对照试验中少数族裔和女性的代表性。

证据综述

2010年7月至2015年7月期间,在PubMed数据库中使用以下关键词识别了所有随机临床试验(RCT):“银屑病”、“特应性皮炎”、“痤疮”、“白癜风”、“脂溢性皮炎”、“斑秃”和“扁平苔藓”。根据美国人口普查数据,将多样化的研究人群定义为包括超过20%的种族或族裔少数群体参与者。通过期刊类型、疾病类型和资金来源比较研究中性别和种族群体的分布。

研究结果

在本次分析纳入的626篇报告RCT的文章中,532篇(85.0%)报告了研究参与者的性别。总体而言,626项国际研究中的52项(11.3%)以及仅在美国进行的97项研究中的58项(59.8%)报告了研究参与者的种族或族裔人口统计学情况。在所有仅在美国招募且报告了种族的RCT中,74.4%的研究参与者为白人。疾病类型与研究队列中的种族多样性程度显著相关(P < 0.001):在美国进行的银屑病研究中,30.0%有超过20%的种族或族裔多样化研究参与者,而痤疮研究为73.9%,湿疹研究为91.7%。

结论及意义

美国的皮肤病临床试验反映了美国人口日益增长的多样性。研究队列在性别和种族/族裔多样性方面的报告仍然不足,尤其是在美国以外进行的研究。

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