Vaccine and Treatment Evaluation Units

疫苗和治疗评估单位

• 批准号: 10199576
• 负责人: EVAN J ANDERSON
• 金额: $ 1143.21万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-13 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10199576
• 关键词: Address; Area; Biological Response Modifier Therapy; Clinical; Clinical Protocols; Clinical Research; Clinical Sciences; Clinical Trials; Communicable Diseases; Complex; Dedications; Devices; Diagnostic; Ebola; Emerging Communicable Diseases; End Point Assay; Enrollment; Environment; Evaluation; Faculty; Female; Funding; Generations; Grant; Immunology; Infrastructure; Institution; International; Laboratories; Lead; Mentors; Mission; National Institute of Allergy and Infectious Disease; Paper; Participant; Pharmacy facility; Population Heterogeneity; Positioning Attribute; Prevention; Procedures; Prognostic Marker; Protocols documentation; Publishing; Quality Control; Research; Research Infrastructure; Research Personnel; Resources; Science; Scientist; Structure; Therapeutic; Training; Translational Research; Universities; Vaccines; ZIKA; base; biodefense; career development; clinical research site; data management; data quality; design; flexibility; member; next generation; pandemic disease; pandemic influenza; predictive marker; protocol development; quality assurance; racial and ethnic; racial diversity; response; retention rate; square foot; study population; vaccinology

Project Summary/Abstract The currently NIAID-funded Vaccine and Treatment Evaluation Unit (VTEU) based at Emory University is ideally positioned to implement the mission of the Infectious Diseases Clinical Research Consortium (IDCRC) . The Emory VTEU is supported by Emory's rich scientific milieu with numerous synergistic grants and various thematic research centers covering all IDCRC scientific priority areas. The Emory VTEU infrastructure relies on two clinical research sites with a total of 16,000 square feet of clinical, laboratory, and pharmacy space and 83 faculty members and staff. Over the past decade as a funded VTEU, we have conducted 51 VTEU protocols, served as lead on 25 trials, performed endpoint assays for 17 studies, and published 22 high impact papers. We have enrolled ~3,000 participants, 55% are female and 37% from diverse racial and ethnic backgrounds with a retention rate of ~93%. With its flexible infrastructure, the Emory VTEU demonstrated surge capacity to contribute to pandemic influenza, Zika, Ebola, and biodefense efforts by prioritizing resources in funds and staffing. The Emory VTEU will build on the current surge capacity by strengthening our partnership with the Georgia Clinical and Translational Science Alliance and collaborating with well-established Emory international partners on a protocol-specific basis. Additionally, to date, our VTEU has trained 28 fellows and junior faculty. We will build on our significant record of accomplishment and advance the IDCRC mission by implementing the following specific aims: 1. Engage a broad range of Emory scientists with expertise in established and newly emerging infectious diseases in the core science of the IDCRC including concept generation and protocol development. 2. Leverage our access to a unique and diverse population and state-of-the-art research infrastructure to implement all components of the IDCRC science, including study conduct, data quality control and assurance procedures, data management, and good clinical, laboratory, and pharmacy practices. 3. Optimize our operational flexibility to further enhance our ability to provide surge capacity to address emerging infectious diseases and pandemic response. 4. Expand our mentoring capacity and enhance career development opportunities for early stage investigators in the areas of vaccinology, infectious diseases diagnostics, therapeutics, and prevention.

项目概要/摘要 目前，NIAID 资助的位于埃默里大学的疫苗和治疗评估单位 (VTEU) 是 处于执行使命的理想位置 传染病临床研究联盟 (IDCRC) 。 埃默里大学 VTEU 得到埃默里大学丰富的科学环境以及众多协同资助和各种 专题研究中心涵盖 IDCRC 所有科学优先领域。埃默里大学 VTEU 基础设施依赖于 两个临床研究场所，临床、实验室和药房空间总计 16,000 平方英尺，以及 83 教职人员和工作人员。在过去的十年里，作为一家受资助的 VTEU，我们已经实施了 51 项 VTEU 协议， 担任 25 项试验的牵头人，对 17 项研究进行终点分析，并发表了 22 篇高影响力论文。 我们已经招募了约 3,000 名参与者，其中 55% 是女性，37% 来自不同种族和民族背景 保留率约为 93%。凭借其灵活的基础设施，埃默里大学 VTEU 展示了超负荷能力 通过优先安排资金和资源，为大流行性流感、寨卡病毒、埃博拉病毒和生物防御工作做出贡献 人员配备。埃默里大学 VTEU 将通过加强与 佐治亚州临床和转化科学联盟并与知名的埃默里国际合作 特定于协议的合作伙伴。此外，迄今为止，我们的 VTEU 已培训了 28 名研究员和初级教师。 我们将在我们取得的重大成就的基础上再接再厉，通过实施 具体目标如下： 1. 广泛吸纳埃默里大学在现有和新出现的传染病方面具有专业知识的科学家 IDCRC 核心科学中的疾病，包括概念生成和方案开发。 2. 利用我们独特且多样化的人口和最先进的研究基础设施来 实施 IDCRC 科学的所有组成部分，包括研究行为、数据质量控制和 保证程序、数据管理以及良好的临床、实验室和药学实践。 3. 优化运营灵活性，进一步增强应对突发事件的能力 新出现的传染病和大流行应对。 4. 扩大我们的指导能力并增加早期职业发展机会 疫苗学、传染病诊断、治疗和预防领域的研究人员。