Tri-Institutional TRAC Clinical Science Core

三机构 TRAC 临床科学核心

• 批准号: 10430740
• 负责人: Daniel W Fitzgerald
• 金额: $ 18.39万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10430740
• 关键词: 5 year old; Address; Aftercare; Area; Award; Biometry; Center for Translational Science Activities; Child; Childhood; Clinical; Clinical Data; Clinical Investigator; Clinical Management; Clinical Sciences; Clinical Trials Unit; Collaborations; Communities; Complement; DNA; Development; Diagnosis; Faculty; Family; Feces; Fostering; Goals; Growth; Haiti; Infrastructure; Interdisciplinary Study; Laboratories; Leadership; Medicine; Mentorship; Monitor; Morbidity - disease rate; Mycobacterium tuberculosis; National Institute of Allergy and Infectious Disease; Pathway interactions; Pediatric cohort; Peripheral Blood Mononuclear Cell; Persons; Policies; Positioning Attribute; Procedures; Program Evaluation; Recurrence; Regimen; Research; Research Design; Research Personnel; Resources; Role; Sampling; Science; Secure; Serum; Site; Sputum; Tanzania; Technical Expertise; Time; Training; Translational Research; Tuberculosis; Underrepresented Minority; United States National Institutes of Health; Urine; Whole Blood; Woman; Work; biobank; career development; clinical center; cohort; data management; early phase clinical trial; epidemiology study; experience; global health; human subject protection; innovation; medical schools; member; mortality; multidisciplinary; population based; sample collection; tuberculosis drugs

The Clinical Science Core: The role of the Clinical Science Core in the Tri-Institutional TB Research Advancement Center (Tri-I TRAC) is to provide new investigators (NIs), new to TB (N2TB) investigators and other TRAC investigators access to existing clinical TB research expertise, resources, and infrastructure. The goals of the Clinical Science Core are the same as the overall TRAC and are to increase the number of new investigators in TB and to foster innovative multidisciplinary TB research. The activities of the core will primarily concentrate on our partner site GHESKIO in Port au Prince, Haiti, which is an established NIAID TB clinical trials unit with 39 years of TB research collaboration with the Tri-I partners. We will also support TB research collaborations at Weill Bugando School of Medicine in Mwanza Tanzania which is also an NIAID supported TB research site. The Clinical Science Core will provide mentorship in clinical TB research to new investigators, provide technical expertise in clinical TB research including study design, data management, clinical laboratory, and biostatistics. The core will provide access to TB clinical cohorts and a large well curated biobank of clinical samples from Haiti. Cohorts include families with multiple members with TB and their contacts, longitudinal treatment cohorts with well characterized post-treatment recurrences, early bacteriacidal activity (EBA) TB trials with intensive monitoring of Mtb quantity in sputum, pediatric cohorts with children under 5 years of age with active TB and controls without TB, and a 3,000 person population based community cohorts with incident TB cases. Biobanked samples include whole blood, serum, peripheral blood mononuclear cells, urine, sputum, stool, and host DNA. We also have a biobank of all 14,360 Mtb clinical isolates collected at GHESKIO from all new TB cases diagnosed over ten years with associated demographic and clinical data. NIs, N2TB investigators and others will have access to these resources. NIs who receive a Developmental Project Award will also receive from the Clinical Science Core a complement of mentorship, career development, technical experts and access to clinical cohorts and biobanked samples. This full package for NIs is the Training to Independence Pathway. The goal is to help NIs secure an independent faculty position and their first R01. NIs, N2TB, and experienced investigators may also apply to the Clinical Science Core for more targeted support which includes technical experts and access to cohort and biobanked samples. This is time limited (<6 months) targeted core support to foster new multidisciplinary research. The Clinical Science Core will work synergistically with the other TRAC Cores to achieve our overall TRAC goals to have 25 NIs successfully compete for a TB related NIH R01 and transition to independence and to attract at least 5 N2TB investigators to TB science over 5 years. Half will be women and at least 20% underrepresented minorities. We will also initiate new lines of translational research to address the five NIAID priorities in TB science with the ultimate goal of ending morbidity and mortality from TB world-wide.

临床科学核心：临床科学核心在三机构结核病研究中的作用 促进中心（Tri-I TRAC）将提供新的研究者（NI）、新的结核病（N2 TB）研究者和 其他TRAC研究人员可以利用现有的临床结核病研究专业知识、资源和基础设施。的 临床科学核心的目标与总体TRAC相同， 结核病研究人员和促进创新的多学科结核病研究。核心小组的活动将 主要集中在我们在海地太子港Au Prince的合作伙伴GHESKIO，这是一个成熟的NIAID TB 临床试验部门与Tri-I合作伙伴进行了39年的结核病研究合作。我们还将支持结核病 坦桑尼亚姆万扎的威尔布甘多医学院也是NIAID的研究合作 支持结核病研究网站。临床科学核心将为新的结核病临床研究提供指导， 研究人员，提供临床结核病研究的技术专长，包括研究设计，数据管理， 临床实验室和生物统计学。核心将提供结核病临床队列和一个大井的访问 海地临床样本的生物库。队列包括多名成员患有结核病的家庭， 他们的接触，纵向治疗队列，治疗后复发，早期 对痰液中结核分枝杆菌数量进行强化监测的杀菌活性（EBA）结核病试验，儿科队列 5岁以下活动性结核病儿童和未患结核病的对照儿童， 基于社区队列的结核病发病病例。生物库样本包括全血、血清、外周血 血液单核细胞、尿液、痰液、粪便和宿主DNA。我们还有一个生物库， 在GHESKIO从10年以上诊断的所有新结核病例中收集的临床分离株， 人口统计学和临床数据。NIs、N2 TB研究人员和其他人将能够获得这些资源。NIS 获得发展项目奖的人还将获得临床科学核心的补充， 指导、职业发展、技术专家以及获得临床队列和生物库样本。这 国家机构的全套方案是"独立培训途径“。目标是帮助国家机构获得独立的 教师职位和他们的第一个R 01。NIs、N2 TB和经验丰富的研究者也可以申请临床 Science Core提供更有针对性的支持，包括技术专家和访问队列和生物库 样品这是有时间限制（<6个月）的有针对性的核心支持，以促进新的多学科研究。的 临床科学核心将与其他TRAC核心协同工作，以实现我们的总体TRAC目标， 有25个国家机构成功竞争结核病相关的NIH R 01，并过渡到独立， 至少5名N2 TB研究人员在5年内从事结核病科学研究。一半是女性，至少20% 代表性不足的少数民族。我们还将启动新的转化研究路线，以解决这五个问题。 NIAID在结核病科学方面的优先事项，最终目标是在全球范围内消除结核病的发病率和死亡率。