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

项目摘要/摘要： 自1979年发表《贝尔蒙特报告》以来的40年里，黑人、土著和其他 COLOR(BIPOC)已经从承担不必要的非自愿参与临床研究的负担到 被排除在享受其利益之外。美国的临床试验人群没有种族或 在道德上代表了美国人口，这些差异已经存在并被研究了几十年。 主流研究主要将这种差异归因于患者不信任、健康素养和后勤障碍， 所有这些都过分强调个人的作用，而没有认识到体制障碍和 结构性种族主义。现在有机会在临床上重新确定种族和民族平等的医学必要性 从使伪科学的生物种族概念合法化的审判到由 当代种族学术。 该项目将介绍心胸外科试验网络的案例研究，该网络是一个成熟的 和由NHLBI创建的成功的临床试验网络，以推进心血管外科治疗 疾病。尽管CTSN将招收不同人群作为其使命的关键要素，但它 未达到其声明的目标，并且在最近的五项研究中，有三项纳入了 超过90%的人是白人和非西班牙裔。这项研究的主要目的是评估网络是否 模型复合招聘BIPOC的系统性障碍，并确定可能的干预措施 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， 研究者的位置性、边缘化个体的生活经验和研究的应用。 将对CTSN试验人口数据和现场人口数据进行量化分析，以 确定是否存在与地理和场地人口限制相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，将选择3-4个网络选址 将与现场工作人员进行案例研究和定性访谈。访谈数据将被汇编并 使用描述性统计(位置)进行审查。网络干预计划和现场评估 将根据项目(实践)的结果开发工具，并可作为其他NIH的模型 网络

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