PRECISE-TBI: PRE Clinical lnteragency research resourcE-TBI

PRECISE-TBI：PRE 临床跨机构研究资源E-TBI

• 批准号: 10935621
• 负责人: C EDWARD DIXON
• 金额: --
• 依托单位: VETERANS HEALTH ADMINISTRATION
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-11-01 至 2026-10-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10935621
• 关键词: Acceleration; Acute; Addendum; Benchmarking; Businesses; Catalogs; Chronic; Clinical; Committee Members; Common Data Element; Communication; Communities; Consensus; Data; Databases; Development; Elements; Employee; FAIR principles; Friends; Funding; Gender Identity; Genes; Geographic Locations; Goals; Home; Human; Industry; Informatics; Infrastructure; Instruction; Knowledge; Knowledge Discovery; Leadership; Length; Maintenance; Mission; Modeling; Nonprofit Organizations; Ontology; Outcome; Pathology; Persons; Pre-Clinical Model; Recording of previous events; Research; Research Personnel; Resources; Role; TBI treatment; Traumatic Brain Injury; data sharing; diversity and inclusion; member; organizational structure; pediatric traumatic brain injury; pre-clinical; programs; software systems; therapy development

PROJECT SUMMARY The overarching mission of this project is to develop a Center entitled PRE-Clinical Interagency reSearch resourcE-Traumatic Brain Injury (PRECISE-TBI) with the mission of accelerating the development of therapies for TBI. PRECISE-TBI will achieve this mission by utilization of an enterprise approach to meet key objectives with targeted strategies. We will also leverage previous collaborative efforts. The organizational structure of PRECISE-TBI incorporates elements from business models and from other research consortia. The strategic missions of the Center are divided into five Cores and milestones will be achieved by activities of Core Directors and members. Leadership of PRECISE-TBI will be the Core Directors (Drs. Dixon, Gurkoff, VandeVord, Martone, LaPlaca, Harris, Floyd) and the Steering Committee Chair, Dr. Adam Ferguson. Leadership will interact with a Steering Committee (comprised of persons representing clinical expertise, other VA programs, other agencies, and all model types) to set objectives, milestones, and deliverables. We will have a Community Committee to be comprised of 100+ persons with wide TBI knowledge and perspectives. Committee members will be divided into task-oriented subcommittees, with oversight/guidance from Leadership and the Steering Committee. Core Directors, Steering Committee Chair, and the Steering Committee members are carefully selected to provide diversity and inclusion in TBI expertise, geographic location, funding history, gender identity, seniority, and research focus. Expertise in both acute and chronic TBI as well as pediatric TBI models will be included. Representatives from industry and non-profit organizations are included in the Steering Committee. The AO/Scientific Writer will compose drafts of documents for finalizing by Committee members. The organization structure of PRECISE-TBI connects investigators in both the Steering Committee and in the Community Committee which facilitates efficiency and wide-range engagement. Each of the Cores has an overarching objective that will be met by aims and milestones. The mission of the Administration Core is to promote effective and efficient communication and interactions between all elements of PRECISE-TBI. The working perspective is that the TBI investigators will act as both “employees” and “customers.” This dual role is because TBI investigators will be engaged to develop (employees) and use (customer) the consensus statements and translational roadmaps. The overarching goal of the Preclinical Model Catalogue Core is the creation, dissemination and maintenance of an online catalogue of preclinical models of TBI as well as create a database of preclinical TBI outcomes that are ontological to human TBI pathologies. The Common Data Elements Core mission is to develop and then benchmark new and existing common data elements using existing data from funded consortia and data from new endeavors. The Informatics Core seeks to fuel knowledge discovery through the development and implementation of a researcher-friendly infrastructure to support data sharing and implement standards and practices to make preclinical TBI data Findable, Accessible, Interoperable, and Reusable (FAIR). The mission of the Field TBI Program Coordination Core is to provide a bridge between the Center and the larger TBI community by leveraging existing infrastructure and growing the interactive community to use Center resources. Collectively, the Leadership, Steering Committee, Community Committee and Cores of PRECISE-TBI will support and accelerate the development of new candidate therapies for TBI.

项目概要 该项目的首要任务是建立一个名为“临床前跨机构研究”的中心 资源创伤性脑损伤 (PRECISE-TBI) 的使命是加速治疗方法的开发 PRECISE-TBI 将通过利用企业方法来实现关键目标来实现这一使命。 我们还将利用以前的合作努力。 PRECISE-TBI 融合了商业模式和其他研究联盟的元素。 该中心的任务分为五个核心，里程碑将通过核心的活动来实现 PRECISE-TBI 的董事和成员将由核心董事（Dixon 博士、Gurkoff 博士、 VandeVord、Martone、LaPlaca、Harris、Floyd）和指导委员会主席 Adam Ferguson 博士。 领导层将与指导委员会（由代表临床专业知识的人员、其他人员组成）进行互动 VA 计划、其他机构和所有模型类型）来设定目标、里程碑和可交付成果。 拥有一个由 100 多名具有广泛 TBI 知识和观点的人员组成的社区委员会。 委员会成员将分为以任务为导向的小组委员会，并接受来自以下机构的监督/指导： 领导层和指导委员会。核心董事、指导委员会主席和指导委员会。 委员会成员经过精心挑选，以提供 TBI 专业知识、地理和多样性方面的多样性和包容性 地点、资助历史、性别认同、资历和急性和慢性 TBI 的研究重点。 以及儿科 TBI 模型也将包括来自行业和非营利组织的代表。 AO/科学作家将撰写文件草稿供最终确定。 PRECISE-TBI 的组织结构将两个指导委员会的研究人员联系起来。 委员会和社区委员会促进了效率和广泛的参与。 核心有一个总体目标，将通过目标和里程碑来实现。 管理核心是促进所有要素之间有效、高效的沟通和互动 PRECISE-TBI 的工作视角是 TBI 调查员既充当“员工”又扮演“员工”的角色。 “客户”。这种双重角色是因为 TBI 调查员将致力于开发（员工）和使用 （客户）共识声明和转化路线图 临床前的总体目标。 模型目录核心是临床前模型在线目录的创建、传播和维护 TBI 模型以及创建与人类 TBI 本体论相关的临床前 TBI 结果数据库 通用数据元素的核心任务是开发新的和现有的数据，然后进行基准测试。 使用来自资助联盟的现有数据和来自新项目的数据的通用数据元素。 信息学核心旨在通过开发和实施 研究人员友好的基础设施，支持数据共享并实施标准和实践 临床前 TBI 数据可查找、可访问、可互操作和可重复使用 (FAIR) 现场 TBI 的使命。 项目协调核心是通过以下方式在中心和更大的 TBI 社区之间架起一座桥梁： 利用现有基础设施并发展互动社区以共同利用中心资源。 PRECISE-TBI 的领导层、指导委员会、社区委员会和核心人员将支持并 加速 TBI 新候选疗法的开发。