RADx-UP CDCC

摘要 迫切需要减少与新冠肺炎相关的发病率和死亡率结果的差异 历史上被边缘化和脆弱的人群受到新冠肺炎大流行的影响不成比例。至 满足这一需求服务不足人群的快速诊断(RADx-UP)计划将 支持社区参与的测试研究项目以及对社会、伦理和行为的影响 (SEBI)研究项目，以了解SARS-CoV-2感染模式并增加获得和 诊断方法在服务不足和/或易受伤害人群中的有效性。杜克大学的临床研究 该研究所(DCRI)、北卡罗来纳大学卫生公平研究中心(CHER)和社区-校园伙伴关系 健康中心(CCPH)建议担任协调和数据收集中心，以提供 管理、指导和全面协调RADx-UP联合体。共同努力，我们的多学科 项目协调经验；新冠肺炎思维领导力；监管科学；社区参与； 健康公平研究；社会公正；成人和儿童研究；统计学；数据科学；和临床研究 信息学将推进RADx-Up计划中项目的目标。我们的首要目标是 实施以社区为中心的方法，建立有效、灵活、参与性和可持续的 CDCC将作为基础设施，最大限度地发挥RADx-UP项目的社区影响 程序。为了实现这一愿景，我们将建立一个由四个核心组成的计划框架。我们的 行政和协调核心将与国家卫生研究院的科学工作人员合作，促进 总体行政管理中的RADX-UP计划。新冠肺炎测试核心将提供建议和 指导新冠肺炎测试方案；整理紧急测试数据；管理快速试点研究 程序。社区和卫生系统参与核心将支持整个社区的实践 RADx-Up计划；在社区之间交流招聘最佳做法方面提供支持， 参与和保留研究参与者；协调研究结果的传播 RADX-UP项目。数据科学和生物统计核心将管理数据收集、集成和 共享RADx-UP计划，包括合并和协调多种不同的数据源 并提供数据标准、数据收集设计、生物统计咨询服务。RADx-UP CDCC 将使用已建立的基础设施和主题专家来实现目标，并将进行定制以满足 RADx-UP社区的各种需求。使用最高的研究标准，我们的团队将 完成美国国立卫生研究院在管理这一至关重要的合作努力方面设定的目标。

ABSTRACT There is an urgent need to reduce disparities in COVID-19 associated morbidity and mortality outcomes in historically marginalized and vulnerable populations disproportionately affected by the COVID-19 pandemic. To address this need the Rapid Acceleration of Diagnostics for Underserved Populations (RADx-UP) program will support Community-Engaged Testing Research Projects and Social, Ethical and Behavioral Implications (SEBI) Research Projects to understand SARS-CoV-2 infection patterns and increase access and effectiveness of diagnostic methods in underserved and/or vulnerable populations. The Duke Clinical Research Institute (DCRI), the UNC Center for Health Equity Research (CHER), and Community-Campus Partnerships for Health (CCPH) propose to serve as the Coordination and Data Collection Center (CDCC) to provide management, direction, and overall coordination of the RADx-UP consortium. Together, our multidisciplinary experience in project coordination; COVID-19 thought leadership; regulatory science; community engagement; health equity research; social justice; adult and child research; statistics; data science; and clinical research informatics will advance the objectives of the projects in the RADx-UP Program. Our overarching goal is to implement a community-centered approach and establish an effective, flexible, participatory, and sustainable CDCC that will serve as the infrastructure to maximize the community impact of projects in the RADx-UP Program. To achieve this vision, we will establish a program framework comprised of four cores. Our Administration and Coordination Core, in collaboration with NIH scientific staff, will facilitate the work of the RADx-UP Program in overarching administrative management. The COVID-19 Testing Core will advise and guide COVID-19 testing protocols; curate emergent testing data; and administer the Rapid Pilot Studies Program. The Community and Health System Engagement Core will support a community of practice across the RADx-UP Program; provide support in exchanging best practices across communities on recruitment, engagement, and retention of study participants; and coordinate the dissemination of study findings from RADx-UP projects. The Data Science and Biostatistics Core will manage data collection, integration, and sharing for the RADx-UP Program including merging and harmonization of multiple and diverse data sources and provide data standards, data collection design, and biostatistics consulting services. The RADx-UP CDCC goals will be met using established infrastructure and subject matter experts and will be customized to meet the variable needs of the RADx-UP community. Using the highest research standards, our team will accomplish the goals set out by the NIH in managing this critically important collaborative effort.