Department of Medicine, Section of Infectious Diseases, Yale School of Medicine, New Haven, Connecticut, United States of America.
Yale School of Public Health, New Haven, Connecticut, United States of America.
PLoS One. 2021 May 6;16(5):e0250735. doi: 10.1371/journal.pone.0250735. eCollection 2021.
As the Coronavirus-2019 (COVID-19) pandemic continues, multiple therapies are rapidly being evaluated for efficacy in clinical trials. Clinical trials should be racially and ethnically representative of the population that will eventually benefit from these medications. There are multiple potential barriers to racial and ethnic minority enrollment in clinical trials, one of which could be that inclusion and exclusion criteria select for certain racial or ethnic groups disproportionately. In this observational cohort study at a single health care system, we examined if there were differences in eligibility for treatment with remdesivir based on clinical trial criteria for racial and ethnic minorities compared to non-Hispanic Whites. 201 electronic medical record charts were reviewed manually. Self-identified Whites were older than other racial or ethnic groups. At the time of presentation, Black, Latinx, and White participants met inclusion criteria for remdesivir at similar rates (72%, 80%, and 73% respectively), and exclusion criteria at similar rates (43%, 38% and 49% for Black, Latinx and White participants respectively). In this study, there was no difference in eligibility for remdesivir based on race or ethnicity alone.
随着 2019 年冠状病毒病(COVID-19)大流行的持续,多种疗法正在临床试验中迅速评估其疗效。临床试验应在种族和民族上代表最终将从这些药物中受益的人群。在临床试验中,少数民族和少数族裔的参与存在多种潜在障碍,其中之一可能是纳入和排除标准不成比例地选择某些种族或族裔群体。在单一医疗保健系统的这项观察性队列研究中,我们研究了根据针对少数族裔和非西班牙裔白人的临床试验标准,在接受瑞德西韦治疗的资格方面是否存在差异。手动审查了 201 份电子病历图表。自报的白人比其他种族或族裔群体年龄更大。在就诊时,黑人、拉丁裔和白人参与者符合瑞德西韦纳入标准的比例相似(分别为 72%、80%和 73%),符合排除标准的比例也相似(黑人、拉丁裔和白人参与者分别为 43%、38%和 49%)。在这项研究中,基于种族或民族本身,瑞德西韦的资格没有差异。