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: 10378331
• 负责人: C EDWARD DIXON
• 金额: --
• 依托单位: VA SALT LAKE CITY HEALTHCARE SYSTEM
• 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/10378331
• 关键词: Acute; Addendum; Benchmarking; Businesses; Catalogs; Chronic; Clinical; Committee Members; Common Data Element; Communication; Communities; Consensus; Data; Databases; Development; Elements; Employee; FAIR principles; 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 该项目的总体使命是开发一个名为临床前机构间研究的中心 资源创伤性脑损伤（精确 - TBI），其使命是加速疗法的发展 对于TBI。精确的TBI将通过利用企业方法来实现关键目标来实现这一任务 有针对性的策略。我们还将利用以前的合作努力。组织结构 Precise-TBI纳入了商业模式和其他研究联盟的元素。策略 该中心的任务分为五个核心，将通过核心活动来实现里程碑 董事和成员。 Precise-Tbi的领导将是核心主任（Dixon博士，Gurkoff， 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互动（完成代表临床专业知识的人，其他 VA程序，其他机构以及所有模型类型），以设置目标，里程碑和可交付成果。我们将 有一个社区委员会要组成100多名具有TBI知识和观点的人。 委员会成员将分为以任务为导向的小组委员会，并有监督/指导 领导力和指导委员会。核心董事，指导委员会主席和转向 精心选择委员会成员，以提供TBI专业知识，地理的多样性和包容性 位置，资金历史，性别认同，资历和研究重点。急性和慢性TBI的专业知识 还将包括小儿TBI模型。来自行业和非营利组织的代表是 包括在指导委员会中。 AO/科学作家将撰写文件草案，以最终确定 委员会成员。 Precise-TBI的组织结构将调查人员连接起来 委员会和社区委员会的设施效率和广泛参与。每个 核心的总体目标将由目标和里程碑实现。任务 管理核心是促进有效有效的沟通和所有要素之间的互动 精确的-TBI。工作的观点是，TBI调查人员将既是“员工”和 “顾客。”该双重角色是因为TBI调查人员将参与（员工）并使用 （客户）共识声明和翻译路线图。临床前的总体目标 模型目录核心是临床前目录的创建，传播和维护 TBI的模型以及创建临床前TBI结果的数据库，该结果是人类TBI的本体论 病理。共同的数据元素核心使命是开发然后基准新的和现有的 使用来自资助的宪法的现有数据以及来自新努力的数据的通用数据元素。这 信息学核心试图通过开发和实施一个 研究人员友好的基础架构，以支持数据共享和实施标准和实践以使 临床前TBI数据可访问，可访问，可互操作和可重复使用（公平）。 TBI的任务 计划协调的核心是通过中心和较大的TBI社区之间的桥梁 利用现有的基础架构并发展互动社区使用中心资源。共同 领导层，指导委员会，社区委员会和精确TBI的核心将支持和 加快TBI新候选疗法的开发。