Vaccine and Treatment Evaluation Units (VTEU)

疫苗和治疗评估单位 (VTEU)

• 批准号: 10457705
• 负责人: HANA M EL SAHLY
• 金额: $ 29.13万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-15 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10457705
• 关键词: Address; Administrator; Area; Clinical; Clinical Research; Clinical Trials; Communicable Diseases; Communication; Communities; Data Analyses; Data Reporting; Development; Disease; Emerging Communicable Diseases; Enteral; Evaluation; Good Clinical Practice; Health Policy; Human; Human Resources; Infection; Influenza; Infrastructure; Laboratory Technicians; Leadership; Medicine; Mentors; National Institute of Allergy and Infectious Disease; Nurses; Patients; Pharmacists; Phase; Physician Assistants; Policies; Population Heterogeneity; Process; Protocols documentation; Public Health; Publications; Regulation; Research; Research Personnel; Research Priority; Role; Sexually Transmitted Diseases; Site; Therapeutic; Vaccines; Virus; clinical application; college; community based participatory research; design; epidemiology study; experience; gastrointestinal; geographic population; improved; interest; mortality; pathogen; prevent; public health emergency; research and development; respiratory; response; therapeutic vaccine; vaccine development; vaccine evaluation

This proposal is for continuation of support for a Vaccine Treatment and Evaluation Unit (VTEU) at Baylor College of Medicine (BCM) and is in response to RFA-AI-18-046. The BCM VTEU will serve as the focal point for clinical research within the Infectious Diseases Clinical Research Consortium (IDCRC), composed of the VTEUs, Leadership Group (LG) and the National Institutes of Allergy and Infectious Diseases (NIAID). The BCM team consists of investigators, administrators, nurses, physician's assistants (PAs), pharmacists, laboratory technicians and support personnel who are highly qualified to perform research to better understand, treat, prevent and control infectious diseases (ID), to perform focused epidemiological studies, and to respond to public health emergencies. The BCM VTEU investigators will utilize their clinical experience and communications/interactions with the larger community of research experts to identify and bring forth clinical research concepts for discussion and review within the IDCRC. In their role within the LG and as directed by the LG policies, the BCM investigators will assist in reviewing and prioritizing all submitted concepts, and then participate in the design and development of approved concepts into protocols for implementation within the VTEU network. During the process of developing a protocol, the BCM VTEU investigators will assess the suitability of the BCM site to perform the study, and/or will help identify additional sites using an existing large network of collaborators, if directed by the LG. If the BCM VTEU is selected as a study site, the BCM VTEU team will implement the study per Good Clinical Practices and applicable regulations, and assist with data analysis and reporting/publication. BCM investigators will leverage their collaborative network to identify and onboard additional sites needed to conduct large scale studies, and provide geographical and population diversity to meet NIAID's priority research area of emerging ID. The project's Specific Aims are: 1. Conduct clinical research addressing clinical vaccine development (Phases 1-4 clinical trials), human experimental infections (influenza and enteric viruses), and evaluations in patients with respiratory, gastrointestinal and sexually transmitted infections; 2. Provide infrastructure and capabilities for rapid expansion to evaluate vaccines/therapeutics for pathogens of public health importance; and 3. Provide mentoring to junior investigators with interest in vaccines & ID clinical research.

该提案旨在继续支持疫苗治疗和评估单位 (VTEU) 贝勒医学院 (BCM) 并回应 RFA-AI-18-046。 BCM VTEU 将 作为传染病临床研究中临床研究的焦点 联盟 (IDCRC)，由 VTEU、领导小组 (LG) 和国家 过敏和传染病研究所 (NIAID)。 BCM 团队由调查员、 行政人员、护士、医师助理 (PA)、药剂师、实验室技术人员和 支持高素质人员进行研究，以更好地理解、治疗、 预防和控制传染病（ID），开展有针对性的流行病学研究，并 应对突发公共卫生事件。 BCM VTEU 研究人员将利用他们的临床 经验以及与更广泛的研究专家社区的沟通/互动 确定并提出临床研究概念，供 IDCRC 内讨论和审查。在 BCM 调查员将协助他们在 LG 内的角色并按照 LG 政策的指示 审查所有提交的概念并确定优先级，然后参与设计和 将批准的概念开发成协议，以便在 VTEU 网络内实施。 在制定方案的过程中，BCM VTEU 调查人员将评估 BCM 地点是否适合进行研究，和/或将有助于使用 如果由 LG 指导，现有的大型合作者网络。如果选择 BCM VTEU 作为 研究地点，BCM VTEU 团队将根据良好临床实践和 适用的法规，并协助数据分析和报告/发布。业务连续性管理 调查人员将利用他们的协作网络来识别并加入其他站点 需要进行大规模研究，并提供地理和人口多样性 满足NIAID新兴ID的优先研究领域。 该项目的具体目标是： 1. 开展针对临床疫苗开发的临床研究（1-4 期临床） 试验）、人体实验感染（流感和肠道病毒）以及评估 患有呼吸道、胃肠道和性传播感染的患者； 2. 提供快速扩展的基础设施和能力来评估 针对具有公共卫生重要性的病原体的疫苗/疗法；和 3. 为对疫苗和感染性疾病临床研究感兴趣的初级研究人员提供指导。