Emerging Infectious Diseases Research Centers Coordination Center (EIDRC CC)

项目摘要/摘要 新出现和再次出现的传染病(EID)暴发，在 南美洲/中美洲、西非/中非和东南亚的高风险地区对美国构成威胁 各州。研究基础设施中有记录的差距限制了快速应对这些疫情的能力。 为了应对这一挑战，国家过敏和传染病研究所(NIAID)正在建立 新兴传染病研究中心网络(EIDRC-NET)，以提高对EIDs的认识； 利用NIAID现有的国际努力；发展有效、灵活和快速部署的能力 疫情研究反应。RTI International和杜克大学提议建立EIDRC 协调中心(EIDRC CC)。RTI-Duke CC将支持EIDRC-Net，该网络将包括 EIDRC、研究站点、CC和NIAID通过实现以下目标：(1)加强EIDRC的协调 通过提供行政、通信、后勤和运营支持实现协作；(2) 通过协调和支持可持续、可扩展和可适应的 研究基础设施以优化暴发间期的资源和知识共享，并 在疾病暴发期间迅速有效地作出反应；(3)通过使用 严格的数据和样本管理系统，内置数据质量保证；(4)确保数据质量 生物检疫、化验和试剂通过协调 EIDRC-Net网站和对跨网络程序的持续审计；以及(5)开发新一代 调查人员和国内科学家通过建立一个试点研究计划来确定、资助和 指导高质量的EIDRC申请者。通过成功实现我们的五个具体目标，RTI-Duke 团队将通过建立可扩展的系统、流程和 资源，不仅提供必要的基础设施，促进EIDRC-Net的性能和实施 OUT CC核心功能在两次暴发期间，但也可以增强和扩展以支持CC 研究暴发期间的激增反应活动。EIDRC CC团队将由多名负责人共同领导 调查人员Donald Brambilla博士(RTI)，生物统计学家，受过高级生物学和 经验丰富的CC领袖，迈克尔·安东尼(Tony)穆迪，医学博士(杜克)，儿科传染病 杜克人类疫苗研究所的专家兼首席医疗官。它们共同带来了广泛的 科学专长、领导力、管理经验和国际研究专长，包括 与EID研究最相关的地理位置。此合作伙伴关系还利用运营 RTI的效率，这是一家大型非营利性研究组织，在超过75个地区和项目设有办事处 拥有杜克大学科学严谨的国家，杜克大学是一所以其尖端医学而闻名的顶尖大学 研究和一个最先进的，由NIAID资助的区域生物遏制实验室的所在地。

PROJECT SUMMARY/ABSTRACT Emerging and re-emerging infectious disease (EID) outbreaks that are occurring with increasing frequency in high-risk areas in South/Central America, West/Central Africa, and Southeast Asia are a threat to the United States. Documented gaps in research infrastructure limit the capacity to rapidly respond to these outbreaks. To address this challenge, the National Institute of Allergy and Infectious Diseases (NIAID) is establishing the Emerging Infectious Disease Research Centers Network (EIDRC-Net) to improve knowledge of EIDs; leverage existing NIAID international efforts; and develop the capacity to mount effective, flexible, and rapid outbreak research responses. RTI International and Duke University propose to establish the EIDRC Coordination Center (EIDRC CC). The RTI-Duke CC will support the EIDRC-Net, which will comprise the EIDRCs, research sites, the CC, and NIAID by realizing the following aims: (1) enhance EIDRC coordination and collaboration by providing administrative, communications, logistical, and operational support; (2) amplify NIAID's capabilities and reach by coordinating and supporting a sustainable, scalable, and adaptable research infrastructure to optimize resources and knowledge sharing during inter-outbreak periods and to respond rapidly and effectively during outbreaks; (3) ensure quality and consistency of study data by using rigorous data and specimen management systems with built-in data quality assurance; (4) ensure quality of biospecimens, assays, and reagents through harmonization of standard operating procedures across EIDRC-Net sites and ongoing audit of cross-network procedures; and (5) develop the next generation of investigators and in-country scientists by establishing a pilot research program that identifies, funds, and mentors high-quality EIDRC applicants. By successfully accomplishing our five specific aims, the RTI-Duke team will shift the outbreak research response paradigm by establishing scalable systems, processes, and resources that not only provide the necessary infrastructure to facilitate EIDRC-Net performance and carry out CC core functions during inter-outbreak periods, but also can be enhanced and expanded to bolster CC research surge response activities during outbreaks. The EIDRC CC team will be co-led by multiple Principal Investigators Donald Brambilla, PhD (RTI), a biostatistician with advanced training in biology and an experienced CC leader, and Michael Anthony (Tony) Moody, MD (Duke), a pediatric infectious disease specialist and Chief Medical Officer of the Duke Human Vaccine Institute. Together they bring extensive scientific expertise, leadership, administrative experience, and international research expertise, including in geographic locations most relevant to the study of EIDs. This partnership also leverages the operational efficiency of RTI, a large nonprofit research organization with regional and project offices in over 75 countries, with the scientific rigor of Duke University, a premier university known for its cutting-edge medical research and home to a state-of-the-art, NIAID-funded Regional Biocontainment Laboratory.