Borno Hala T, Zhang Sylvia, Gomez Scarlett
Department of Medicine, Division of Hematology/Oncology, University of California San Francisco, San Francisco, CA, USA.
Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.
Contemp Clin Trials Commun. 2020 Jul 30;19:100630. doi: 10.1016/j.conctc.2020.100630. eCollection 2020 Sep.
Racial/ethnic disparities in disease burden have gained the spotlight in the United States with the spread of SARS-CoV-2 and surge of COVID-19 cases. The problem of underrepresentation in clinical research persists today. In light of the considerable COVID-19 disparities observed, this study sought to assess the race reporting and representation among COVID-19 therapeutic studies published to date.
All published COVID-19 treatment-related clinical research studies with study participants in the United States were identified. For each study, the date published, treatment investigated, study design, race/ethnicity of participants, sample size and study site were recorded. For each study site, the race/ethnicity demographics of confirmed COVID-19 positive cases were identified utilizing online publicly available department of public health data.
Six studies (n = 3, observational; n = 3, randomized clinical trial) have been published to date with participants in the United States. A subset (n = 4) reported race/ethnicity data in the publication. Black patients were underrepresented in all studies relative to the affected population in the cities in which the studies took place.
Given that racial/ethnic disparities in COVID-19 disease burden and outcomes have emerged in the United States, it is essential that all investigators uniformly report race/ethnicity data as well as attempt, in earnest, to obtain representativeness among study participants in order to ensure that we do not develop a further widening of the treatment gap during this pandemic.
随着严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的传播和新冠肺炎病例的激增，美国疾病负担方面的种族/族裔差异受到了关注。临床研究中代表性不足的问题至今仍然存在。鉴于观察到的新冠肺炎方面的显著差异，本研究旨在评估迄今为止发表的新冠肺炎治疗研究中的种族报告情况和代表性。
确定了所有已发表的、研究参与者在美国的与新冠肺炎治疗相关的临床研究。对于每项研究，记录其发表日期、研究的治疗方法、研究设计、参与者的种族/族裔、样本量和研究地点。对于每个研究地点，利用在线公开的公共卫生部门数据确定确诊的新冠肺炎阳性病例的种族/族裔人口统计学特征。
迄今为止，已有六项研究（n = 3项观察性研究；n = 3项随机临床试验）发表，研究参与者在美国。其中一部分研究（n = 4）在发表文章时报告了种族/族裔数据。在所有研究中，相对于研究开展城市中受影响的人群，黑人患者的代表性不足。
鉴于美国已出现新冠肺炎疾病负担和结局方面的种族/族裔差异，所有研究人员必须统一报告种族/族裔数据，并切实努力在研究参与者中实现代表性，以确保在这场大流行期间我们不会使治疗差距进一步扩大。
