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.

项目摘要 该项目的首要使命是建立一个名为临床前跨部门研究的中心 资源E-创伤性脑损伤（PRECISE-TBI），其使命是加速治疗方法的开发 对于TBI。PRECISE-TBI将通过利用企业方法实现关键目标来实现这一使命 有针对性的战略。我们还将利用以前的合作努力。的组织结构 PRECISE-TBI融合了商业模式和其他研究联盟的元素。战略 中心的任务分为五个核心，通过核心活动实现里程碑 董事和成员。PRECISE-TBI的领导层将由核心董事（狄克逊博士、Gurkoff博士、 VandeVord，Martone，LaPlaca，Harris，弗洛伊德）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组成， VA计划、其他机构和所有模型类型）来设定目标、里程碑和交付成果。我们将 拥有一个由100多名具有广泛TBI知识和观点的人士组成的社区委员会。 委员会成员将被分为以任务为导向的小组委员会，并由 领导和指导委员会。核心董事、指导委员会主席和 委员会成员经过精心挑选，以提供TBI专业知识的多样性和包容性， 地点、资助历史、性别认同、资历和研究重点。急性和慢性TBI的专业知识 以及儿科TBI模型。来自工业界和非营利组织的代表是 在指导委员会中。AO/科学撰稿人将撰写文件草案，以便通过以下方式定稿： 委员会成员。PRECISE-TBI的组织结构将指导委员会 委员会和社区委员会，促进效率和广泛的参与。中的每 核心会议有一个总体目标，将通过目标和里程碑来实现。联合国的使命 行政核心是促进各要素之间有效和高效的沟通和互动 精准TBI工作的角度是，TBI调查人员将作为"雇员"， "顾客"这种双重角色是因为TBI调查人员将从事开发（员工）和使用 （客户）共识声明和翻译路线图。临床前研究的总体目标 模型目录核心是创建，传播和维护临床前的在线目录 TBI模型以及创建对人类TBI具有本体论意义的临床前TBI结果数据库 病理学通用数据元素核心的使命是开发新的和现有的数据元素，然后对其进行基准测试 共同数据元素，使用现有的数据，从资助财团和数据，从新的努力。的 信息学核心旨在通过开发和实施一个 研究人员友好的基础设施，以支持数据共享，并实施标准和实践， 临床前TBI数据可查找、可访问、可互操作且可重复使用（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社区之间提供桥梁 利用现有的基础设施和发展互动社区来使用中心资源。总的来说， PRECISE-TBI的领导层、指导委员会、社区委员会和核心将支持和 加快开发新的TBI候选疗法。