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