Beyond Diversity: Addressing Equity and Enrollment in a Clinical Trial Network Model

超越多样性：解决临床试验网络模型中的公平性和注册问题

• 批准号: 10415758
• 负责人: Anne Christine Gelijns
• 金额: $ 4.88万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10415758
• 关键词: Address; American; Belmont Report; Biological; Cardiovascular Diseases; Case Study; Clinical Research; Clinical Trials; Clinical Trials Network; Color; Country; Data; Discrimination; Elements; Enrollment; Ensure; Ethics; Evaluation; Funding; Geographic Locations; Goals; Indigenous; Individual; Intervention; Interview; Justice; Logistics; Measures; Medical; Mission; Modeling; Names; National Heart, Lung, and Blood Institute; Nature; Not Hispanic or Latino; Operative Surgical Procedures; Patients; Population; Population Heterogeneity; Publications; Race; Research; Research Personnel; Role; Scholarship; Site; Structural Racism; Structure; United States; United States National Institutes of Health; base; distrust; experience; health literacy; improved; network models; parity; patient population; racial and ethnic; racial and ethnic disparities; racism; recruit; social; statistics; theories; tool

Project Summary/Abstract: In the 40 years since the publication the Belmont Report in 1979 Black, Indigenous, and other people of color (BIPOC) have gone from bearing an undue burden of involuntary participation in clinical research to being excluded from receiving its benefits. Clinical trial populations in the United States are not racially or ethically representative of the US population and these disparities have existed and been studied for decades. Prevailing research primarily attributes such disparities to patient distrust, health literacy, and logistical barriers, all of which overemphasize the role of the individual and do not recognize the role of institutional barriers and structural racism. An opportunity exists to reframe the medical imperative of racial and ethnic parity in clinical trials from one that legitimizes pseudoscientific notions of biological race to one of justice informed by contemporary racial scholarship. This project will present a case study of the Cardiothoracic Surgical Trial Network, a well-established and successful clinical trials network created by the NHLBI to advance the surgical treatment of cardiovascular disease. Despite naming the enrollment of diverse populations as key element of its mission, the CTSN has not reached its stated goal and three of the five most recent studies in have enrolled patient populations that were more than 90% white and non-Hispanic. The primary aim of this study is to assess whether the network model compounds systemic barriers to the recruitment of BIPOC and identify possible interventions using the interdisciplinary framework of Critical Race Theory. Critical Race Theory emphasizes the social construction of race, the structural nature of racism, the positionality of the researcher, the lived experience of marginalized individuals, and the application of research. A quantitative analysis of CTSN trial demographic data and site demographic data will be performed to establish whether there are racial and ethnic disparities related to geographic and site population constraints (structural/institutional discrimination). Based on the quantitative analysis, 3-4 network sites will be chosen for case studies and qualitative interviews will be conducted with site staff. Interview data will be compiled and reviewed using descriptive statistics (positionality). An intervention plan for the network and a site evaluation tool will be developed based on the results of the project (praxis) and can serve as a model for other NIH networks

项目概要/摘要： 自1979年《贝尔蒙特报告》发表以来的40年里， 颜色（BIPOC）已经从承担非自愿参与临床研究的过度负担， 被排除在受益之外。美国的临床试验人群不分种族或性别 这些差异已经存在并被研究了几十年。 流行的研究主要将这种差异归因于患者的不信任，健康素养和后勤障碍， 所有这些都过分强调个人的作用，而不承认体制障碍的作用， 结构性种族主义存在一个机会，以重新制定医疗必要的种族和民族平等的临床 从使生物种族的伪科学概念合法化的审判到由生物种族告知的正义审判 当代种族学 本项目将介绍心胸外科试验网络的案例研究， NHLBI创建的成功临床试验网络，以推进心血管疾病的外科治疗 疾病尽管CTSN将招募不同人群列为其使命的关键要素，但CTSN 没有达到其既定目标，最近的五项研究中有三项招募了 超过90%是白色和非西班牙裔。本研究的主要目的是评估网络是否 该模型加剧了BIPOC招募的系统性障碍，并使用 批判种族理论的跨学科框架。 批判种族理论强调种族的社会建构，种族主义的结构性， 研究者的立场，边缘化个体的生活经验，以及研究的应用。 将对CTSN试验人口统计数据和研究中心人口统计数据进行定量分析， 确定是否存在与地理和现场人口限制有关的种族和民族差异 （结构性/体制性歧视）。在定量分析的基础上，选择3-4个网络站点， 并会与地盘职员进行个案研究及质性面谈。将收集访谈数据， 使用描述性统计（位置性）进行审查。网络干预计划和现场评估 将根据项目（praxis）的结果开发一个工具，并可作为其他NIH的模型 网络