Transforming Research and Clinical Knowledge in Traumatic Brain Injury

描述（由申请人提供）：创伤性脑损伤（TBI）的有效治疗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;估计有320万至530万人患有长期的身体疾病， TBI的认知和心理健康残疾，每年的直接和间接费用估计超过600亿美元。研究人员、慈善机构和行业领导者的独特公私合作伙伴关系汇集在创伤性脑损伤（TRACK-TBI）多中心转化研究和临床知识提案中，共同承担加速TBI临床研究的使命。目标是创建一个大型的高质量TBI数据库，整合临床，成像，蛋白质组学，基因组学和结果生物标志物，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，改善结果评估，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，允许对治疗和结局进行有意义的比较，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谱受试者的临床、成像、蛋白质组学、基因组学和结果生物标志物，并提供分析工具和资源以支持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，这些生物标志物将改善TBI的分类，允许适当选择和分层患者进行临床试验，并有助于开发新的TBI分类法。 具体目标3。评价由广泛的TBI通用数据元素组成的灵活结局评估组合，该组合能够评估所有恢复阶段和所有TBI严重程度水平的多个结局领域。 具体目标4。确定哪些测试，治疗和服务对TBI患者有效且适当，并使用此证据推荐提供最佳价值的实践。该项目将通过创建一个开放获取的信息共享空间直接影响公共卫生，该信息共享空间包含强大的通用数据元素，这将使国际研究合作成为现实。将收集和分析损伤谱中3，000名受试者（11个部位）的详细临床数据，沿着CT/MRI成像、血液生物标本和详细结局，从而允许识别/验证生物标志物，并识别可能预测结局的结构异常，朝着TBI的新分类法迈进。综合数据库、成像和生物样本库的基础设施将为当前和未来的国际研究人员创建一个高质量的传统数据库。

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.