Tri-Institutional TRAC Clinical Science Core

三机构 TRAC 临床科学核心

基本信息

批准号：
10675740
负责人：
Daniel W Fitzgerald
金额：
$ 20.54万
依托单位：
WEILL MEDICAL COLL OF CORNELL UNIV
依托单位国家：
美国
项目类别：
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/10675740
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 Institution 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

项目摘要

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进步中心 (Tri-I TRAC) 旨在为新研究者 (NI)、新结核病 (N2TB) 研究者和其他 TRAC 研究人员可以获得现有的临床结核病研究专业知识、资源和基础设施。这临床科学核心的目标与总体 TRAC 相同，都是增加新的数量结核病研究人员并促进创新的多学科结核病研究。核心的活动将主要集中在我们位于海地太子港的合作伙伴网站 GHESKIO，这是一个已建立的 NIAID TB 临床试验部门与 Tri-I 合作伙伴拥有 39 年的结核病研究合作经验。我们也将支持结核病坦桑尼亚姆万扎威尔·布干多医学院 (Weill Bugando School of Medicine) 的研究合作，该医学院也是 NIAID 支持结核病研究网站。临床科学核心将为新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业知识，包括研究设计、数据管理、临床实验室和生物统计学。核心区将提供结核病临床队列和一口大井的通道精心策划的海地临床样本生物库。队列包括有多位结核病成员的家庭以及他们的接触者、具有明确治疗后复发特征的纵向治疗队列、早期杀菌活性 (EBA) 结核病试验，密切监测痰液、儿科队列中的结核分枝杆菌数量包括患有活动性结核病的 5 岁以下儿童和未患有结核病的对照人群，以及 3,000 人的人口基于社区队列的结核病病例。生物样本库样本包括全血、血清、外周血血液单核细胞、尿液、痰、粪便和宿主 DNA。我们还拥有一个包含全部 14,360 Mtb 的生物库 GHESKIO 从 10 年来诊断的所有新结核病病例中收集的临床分离株人口统计和临床数据。 NI、N2TB 调查人员和其他人员将可以访问这些资源。 NI 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的机会。这 NI 的完整套餐是独立培训途径。目标是帮助NI获得独立的教职职位和他们的第一个 R01。 NI、N2TB 和经验丰富的研究人员也可以申请临床科学核心提供更有针对性的支持，包括技术专家以及队列和生物库的访问权限样品。这是有时间限制（<6 个月）的有针对性的核心支持，旨在促进新的多学科研究。这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 NI 成功竞争结核病相关的 NIH R01 并过渡到独立并吸引至少 5 名 N2TB 研究者在 5 年内从事结核病科学工作。一半是女性，至少 20% 代表性不足的少数群体。我们还将启动新的转化研究领域来解决五个问题 NIAID 优先关注结核病科学，最终目标是消除全世界结核病的发病率和死亡率。