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如何使英语水平有限的受试者在临床试验中的代表性更加公平?

How Should Representation of Subjects With LEP Become More Equitable in Clinical Trials?

机构信息

Fourth-year medical student at the Northwestern University Feinberg School of Medicine in Chicago, Illinois.

Fourth-year medical student the Northwestern University Feinberg School of Medicine in Chicago, Illinois.

出版信息

AMA J Ethics. 2022 Apr 1;24(4):E319-325. doi: 10.1001/amajethics.2022.319.

DOI:10.1001/amajethics.2022.319
PMID:35405059
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9052781/
Abstract

Underrepresentation of individuals with limited English proficiency (LEP) who speak Spanish is ongoing in phase 3 biomedical clinical trials and exacerbates health inequity. This article suggests strategies for increasing representation of Spanish speakers in clinical rials by emphasizing the importance of early engagement with Spanish language communities, inclusive participant recruitment, and collaborative trial design and implementation. Although investigators and institutions administering government-funded research must meet federal requirements for language assistance, journal editors, peer reviewers, institutional review board members, academic health centers, and all beneficiaries of the biomedical and behavioral research enterprise in the United States must motivate linguistic inclusion.

摘要

在 3 期生物医学临床试验中,讲西班牙语的英语水平有限(LEP)个体的代表性不足仍在持续,这加剧了健康不平等。本文提出了通过强调早期与西班牙语社区的接触、包容性的参与者招募以及协作的试验设计和实施来增加临床试验中西班牙语参与者代表性的策略。尽管进行政府资助研究的研究人员和机构必须符合语言援助的联邦要求,但期刊编辑、同行评审员、机构审查委员会成员、学术医疗中心以及美国生物医学和行为研究企业的所有受益者都必须激励语言包容性。

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Lancet Reg Health Am. 2022 Feb;6. doi: 10.1016/j.lana.2021.100111. Epub 2021 Nov 8.
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Evaluating the frequency of English language requirements in clinical trial eligibility criteria: A systematic analysis using ClinicalTrials.gov.评估临床试验入选标准中英语语言要求的频率:使用 ClinicalTrials.gov 的系统分析。
PLoS Med. 2021 Sep 14;18(9):e1003758. doi: 10.1371/journal.pmed.1003758. eCollection 2021 Sep.
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Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials.评估种族/少数民族、女性和老年人在疫苗临床试验中的纳入情况。
JAMA Netw Open. 2021 Feb 1;4(2):e2037640. doi: 10.1001/jamanetworkopen.2020.37640.
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Barriers and facilitators of clinical trial enrollment in a network of community-based pediatric oncology clinics.社区儿科肿瘤诊所网络中临床试验入组的障碍和促进因素。
Pediatr Blood Cancer. 2020 Apr;67(4):e28023. doi: 10.1002/pbc.28023. Epub 2019 Sep 25.
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