RADx-UP CDCC

摘要 迫切需要减少各地区与 COVID-19 相关的发病率和死亡率结果的差异 历史上被边缘化的弱势群体尤其受到 COVID-19 大流行的影响。至 为了满足这一需求，快速加速服务不足人群诊断 (RADx-UP) 计划将 支持社区参与的测试研究项目及其社会、道德和行为影响 (SEBI) 研究项目旨在了解 SARS-CoV-2 感染模式并增加获取和 诊断方法在服务不足和/或弱势群体中的有效性。杜克临床研究 研究所 (DCRI)、北卡罗来纳大学健康公平研究中心 (CHER) 和社区校园合作伙伴关系 卫生局 (CCPH) 提议充当协调和数据收集中心 (CDCC)，以提供 RADx-UP 联盟的管理、指导和总体协调。我们的多学科共同努力 有项目协调经验； COVID-19 思想领导力；监管科学；社区参与； 健康公平研究；社会正义；成人和儿童研究；统计数据;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。我们的总体目标是 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 计划。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 NIH 科学人员合作，促进该中心的工作 RADx-UP 总体行政管理计划。 COVID-19 测试核心将提供建议并 指导 COVID-19 检测方案；整理紧急测试数据；并管理快速试点研究 计划。社区和卫生系统参与核心将支持跨领域的实践社区 RADx-UP 计划；为跨社区交流招聘方面的最佳实践提供支持， 研究参与者的参与度和保留率；并协调研究结果的传播 RADx-UP 项目。数据科学和生物统计学核心将管理数据收集、整合和 RADx-UP 计划的共享，包括多种不同数据源的合并和协调 并提供数据标准、数据采集设计、生物统计咨询服务。 RADx-UP CDCC 将利用现有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 社区的不同需求。我们的团队将采用最高的研究标准 实现 NIH 在管理这一至关重要的合作工作中设定的目标。

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.