Vaccine and Treatment Evaluation Units (VTEU)

疫苗和治疗评估单位 (VTEU)

• 批准号: 10414364
• 负责人: HANA M EL SAHLY
• 金额: $ 155.58万
• 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: 2021-05-19 至 2023-04-13
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10414364
• 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.

这项建议是为了继续支持疫苗治疗和评价股 在贝勒医学院（Baylor College of Medicine，简称BLM），是对RFA-AI-18-046的回应。BCM VTEU将 作为传染病临床研究中临床研究的焦点 联合会（IDCRC），由VTEU、领导小组（LG）和国家 过敏和传染病研究所（NIAID）。调查小组由调查人员组成， 管理人员、护士、医师助理（PA）、药剂师、实验室技术人员和 支持人员谁是高素质的执行研究，以更好地了解，治疗， 预防和控制传染病，进行重点流行病学研究， 应对突发公共卫生事件。研究人员将利用他们的临床 与更大的研究专家社区的经验和沟通/互动， 确定并提出临床研究概念，以便在IDCRC内进行讨论和审查。在 根据他们在LG内部的角色以及LG政策的指导，调查员将协助 审查并优先考虑所有提交的概念，然后参与设计， 将核准的概念发展成在VTEU网络内实施的协议。 在制定方案的过程中，欧盟委员会的研究人员将评估 研究中心进行研究的适宜性，和/或将有助于使用 现有的大型合作者网络，如果由LG指导。 研究中心，CNOVTEU团队将按照药物临床试验质量管理规范实施研究， 适用的法规，并协助数据分析和报告/出版。BCM 调查人员将利用他们的合作网络， 需要进行大规模的研究，并提供地理和人口多样性， 满足NIAID的新兴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），人类实验感染（流感和肠道病毒），以及 患有呼吸道、胃肠道和性传播感染的患者; 2.为快速扩展提供基础架构和能力，以评估 对公共卫生具有重要意义的病原体的疫苗/治疗剂;以及 3.为对疫苗和ID临床研究感兴趣的初级研究人员提供指导。