Transforming Research and Clinical Knowledge in Traumatic Brain Injury

改变创伤性脑损伤的研究和临床知识

基本信息

批准号：
8742027
负责人：
Ramon Diaz-Arrastia
金额：
$ 537.27万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-30 至 2018-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8742027
关键词：
Achievement Age Anatomy Antiplatelet Drugs Beds Biological Markers Blood Brain Concussion Candidate Disease Gene Caring Categories Classification Clinical Clinical Data Clinical Research Clinical Trials Clinical Trials Design Cognition Cognitive Collaborations Coma Common Data Element Craniotomy Data Data Set Databases Development Diagnosis Diagnostic Diffusion Magnetic Resonance Imaging Direct Costs Economic Burden Enrollment Facilities and Administrative Costs Floor Functional Magnetic Resonance Imaging Future Future Generations Genetic Markers Genetic Polymorphism Genomics Glasgow Outcome Scale Goals Gold Home environment Image Industry Industry Collaborators Informatics Injury International Intervention Intracranial Hemorrhages Knowledge Lead Life Magnetic Resonance Imaging Mental Health Methods Mission Molecular Neurocognitive Neuropsychological Tests Outcome Outcome Assessment Outpatients Patients Phase Phenotype Pilot Projects Proteomics Public Health Quality of life Recovery Research Research Infrastructure Research Personnel Resources Rest Sample Size Services Severities Site Stratification System Taxonomy Testing Time Traumatic Brain Injury Treatment outcome Validation base clinical practice comparative effectiveness compare effectiveness cost disability economic impact effective therapy effectiveness research experience flexibility follow-up forging functional status health economics improved indexing next generation novel strategies outcome forecast prognostic public health relevance public-private partnership repaired repository response to injury social tool

项目摘要

DESCRIPTION (provided by applicant): Effective treatment of traumatic brain injury (TBI) remains one of the greatest unmet needs in public health. Each year in the US, at least 1.7 million people suffer TBI; an estimated 3.2 to 5.3 million people live with the long-term physical, cognitive, and psychological health disabilities of TBI, with annual direct and indirect costs estimated at over $60 billion. The unique public-private partnership of investigators, philanthropy, and industry leaders brought together in the multicenter Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) proposal share a mission to accelerate clinical research in TBI. The goal is to create a large, high quality TBI database that integrates clinical, imaging, proteomic, genomic, and outcome biomarkers, and provides analytic tools and resources to establish more precise methods for TBI diagnosis and prognosis, improve outcome assessment, and compare the effectiveness and costs of tests, treatments, and services. The investigators hypothesize that this approach will deliver better characterization and stratification of patients, allowing meaningful comparisons of treatments and outcomes and thereby improving the next generation of clinical trials. Specific Aim 1. To create a widely accessible, comprehensive TBI Information Commons that integrates clinical, imaging, proteomic, genomic, and outcome biomarkers from subjects across the age and injury spectra, and provides analytic tools and resources to support TBI research. Specific Aim 2. To validate imaging, proteomic, and genetic biomarkers that will improve classification of TBI, permit appropriate selection and stratification of patients for clinical trils, and contribute to the development of a new taxonomy for TBI. Specific Aim 3. To evaluate a flexible outcome assessment battery comprised of a broad range of TBI common data elements that enables assessment of multiple outcome domains across all phases of recovery and at all levels of TBI severity. Specific Aim 4. To determine which tests, treatments, and services are effective and appropriate for which TBI patients, and use this evidence to recommend practices that offer the best value. The project will directly impact public health by creating an open-access Information Commons populated with robust Common Data Elements that will make international research collaboration a reality. Detailed clinical data on 3,000 subjects (11 sites) across the injury spectrum, along with CT/MRI imaging, blood biospecimens, and detailed outcomes, will be collected and analyzed, permitting the identification/validation of biomarkers, and identification of structural abnormalities that may be predictive of outcomes, making strides toward a new taxonomy for TBI. The infrastructure of integrated databases and imaging and biosample repositories will create a high quality, legacy database for current and future generations of international researchers.

描述（由申请人提供）：有效治疗创伤性脑损伤（TBI）仍然是公共卫生领域最大的未满足需求之一。在美国，每年至少有 170 万人患有 TBI；据估计，有 3.2 至 530 万人长期患有身体疾病， TBI 造成的认知和心理健康障碍，每年造成的直接和间接损失估计超过 600 亿美元。由研究人员、慈善机构和行业领导者组成的独特公私合作伙伴关系在多中心创伤性脑损伤研究和临床知识转化 (TRACK-TBI) 提案中汇聚一堂，共同致力于加速 TBI 的临床研究。目标是创建一个大型、高质量的 TBI 数据库，整合临床、影像、蛋白质组、基因组和结果生物标志物，并提供分析工具和资源，以建立更精确的 TBI 诊断和预后方法，改进结果评估，并比较测试、治疗和服务的有效性和成本。研究人员假设，这种方法将提供更好的患者特征和分层，从而可以对治疗和结果进行有意义的比较，从而改善下一代临床试验。具体目标 1. 创建一个可广泛访问的综合性 TBI 信息共享空间，整合来自不同年龄和损伤范围的受试者的临床、成像、蛋白质组、基因组和结果生物标志物，并提供分析工具和资源来支持 TBI 研究。具体目标 2. 验证影像学、蛋白质组学和遗传生物标志物，以改善 TBI 的分类，允许对临床试验的患者进行适当的选择和分层，并有助于开发 TBI 新的分类法。具体目标 3. 评估由广泛的 TBI 通用数据元素组成的灵活结果评估组合，该组合能够评估所有恢复阶段和所有 TBI 严重程度的多个结果领域。具体目标 4. 确定哪些测试、治疗和服务对哪些 TBI 患者有效且合适，并利用这些证据来推荐提供最佳价值的实践。该项目将通过创建一个包含强大通用数据元素的开放访问信息共享空间来直接影响公共健康，从而使国际研究合作成为现实。将收集和分析 3,000 名受试者（11 个部位）整个损伤范围的详细临床数据，以及 CT/MRI 成像、血液生物样本和详细结果，从而能够识别/验证生物标记物，并识别可能导致结构异常的结构异常。预测结果，朝着 TBI 的新分类迈进。集成数据库以及成像和生物样本存储库的基础设施将为当前和未来几代国际研究人员创建一个高质量的遗留数据库。