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得到满足的需求之一。在美国，每年至少有170万人遭受脑外伤；据估计，有320万至530万人生活在长期的体检中， 脑损伤造成的认知、心理和健康障碍，每年的直接和间接成本估计超过600亿美元。由研究人员、慈善机构和行业领导者组成的独特的公私合作伙伴关系汇聚在创伤性脑损伤的多中心转型研究和临床知识(TRACK-TBI)提案中，共同肩负着加快创伤性脑损伤临床研究的使命。其目标是创建一个大型、高质量的脑损伤数据库，该数据库集成了临床、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，以建立更精确的脑损伤诊断和预后方法，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，允许对治疗和结果进行有意义的比较，从而改进下一代临床试验。 具体目标1.创建一个广泛可访问的、全面的脑损伤信息共享空间，整合来自不同年龄和损伤谱的受试者的临床、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脑损伤研究。 具体目的2.验证影像、蛋白质组和遗传生物标记物将改善脑外伤的分类，允许对临床试验的患者进行适当的选择和分层，并为脑外伤新的分类学的发展做出贡献。 具体目标3.评价一个灵活的结果评估小组，该小组由广泛的全面创伤共同数据要素组成，能够评估所有复苏阶段和所有严重程度的全面创伤的多个结果领域。 具体目标4.确定哪些测试、治疗和服务对哪些脑外伤患者有效和合适，并使用这些证据来推荐提供最佳价值的做法。该项目将通过创建一个开放获取的信息共享空间来直接影响公众健康，其中包含强大的公共数据元素，这将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)的详细临床数据，以及CT/MRI成像、血液生物显微镜和详细结果，从而能够识别/验证生物标记物，并识别可能预测结果的结构异常，朝着脑外伤的新分类迈进一大步。综合数据库、成像和生物样本储存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产数据库。

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.