Clinical Core

临床核心

• 批准号: 10593166
• 负责人: MAUNANK SHAH
• 金额: $ 11.13万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-16 至 2027-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10593166
• 关键词: AIDS clinical trial group; Accountability; Address; Adherence; Award; Baltimore; Belief; Bioethics; Biological Specimen Banks; Brazil; Caring; Categories; Cities; Clinic; Clinical; Clinical Investigator; Clinical Research; Clinical Sciences; Clinical Services; Clinical Trials; Collaborations; Communication; Communities; Country; Coupled; Databases; Detection; Development; Diagnostic; Disease; Ensure; Environment; FAIR principles; Faculty; Feedback; Fostering; Foundations; Funding; Generations; Goals; Grant; HIV; Health; Human Resources; Human Subject Research; Incidence; Incubated; India; Infection; Infrastructure; Institution; Institutional Review Boards; Interdisciplinary Study; International; International Maternal Pediatric Adolescent AIDS Clinical Trials; Investigation; K-Series Research Career Programs; Knowledge; Link; Measures; Mentors; Mentorship; Methodology; Modeling; Morbidity - disease rate; Natural History; Newsletter; Pathogenesis; Patients; Policies; Population; Prevention; Preventive therapy; Process; Public Health; Recovery; Reporting; Research; Research Activity; Research Infrastructure; Research Methodology; Research Personnel; Research Priority; Research Support; Resources; Series; South Africa; Specimen; Stream; Structure; Sum; Talents; Therapeutic; Training; Translating; Translational Research; Tuberculosis; Uganda; United States National Institutes of Health; Universities; Update; Work; Writing; career; case finding; clinical care; clinical implementation; clinical research site; co-infection; cohort; comorbidity; cost; data resource; epidemiology study; global health; implementation intervention; improved; innovation; interdisciplinary collaboration; material transfer agreement; meetings; mortality; multidisciplinary; next generation; novel; patient population; public health research; searchable database; skills; supportive environment; symposium; synergism; transmission process; web site

ABSTRACT – JHU TRAC CLINICAL CORE (CC) Tuberculosis (TB) remains a major global health problem and transformative clinical and translational science research is needed to meaningfully bend the curve of TB incidence, transmission, morbidity and mortality. The Johns Hopkins University (JHU) Center for Tuberculosis Research (CTR) is a global leader in innovation and investigation, with ongoing research that spans the spectrum of clinical sciences and aligns strongly with the NIH Strategic Research Priorities for TB research. However, to make further progress towards the WHO END TB goals, it is critical to foster new interdisciplinary research and promote a new generation of TB researchers and leaders. Therefore, the overarching goal of the JHU TRAC Clinical Core (CC) is to foster transformational TB clinical research by providing access to populations, mentoring, and material support for the conduct of clinical and translational science studies. The CC will add value and augment essential research infrastructure to develop hypotheses, promote collaboration, and make resources accessible to foster and develop the next generation of TB researchers. The foundation of the CC is our extensive patient populations and biospecimen repositories domestically and internationally, coupled with a depth of technical, regulatory, and clinical research expertise. The CC will strengthen clinical TB research capacity by bridging scientific resources at JHU that are currently separated by departmental, physical, and logistical barriers. To this end, we propose to first create novel avenues for exchange of research methods and ideas among new and established investigators (Aim 1). We will participate in the structured weekly TRAC Seminar Series, with a focus on research in TB detection, prevention, treatment, and cross-cutting topics, as well as the TRAC K-Club and K2R Club, and annual TB Scientific Meeting and TRAC Data Fair. We will deliver improved opportunities for New and Early Stage Investigators (NI/ESI) to present and receive feedback, while strengthening collective understanding of novel developments in TB clinical science and fostering cross-disciplinary mentorship and collaborations. Given the wide-reaching research activities in the JHU TRAC, NI and ESI will benefit from coordinated access and knowledge of research opportunities, access to international and US clinics, patient cohorts and consortia, and specimen repositories (Aim 2). A CC-supported Research Liaison will manage a consolidated searchable database of JHU TRAC resources and research, and provide direct assistance and methodological guidance to NI/ESI and trainees for linking to mentors, research opportunities, and data resources. We will ensure that NI/ESI have the resources to successfully launch and execute clinical research (Aim 3) with provisions for a shared CC Study Coordinator. Trainees will be supported in management of regulatory processes and study implementation. JHU has excellent TB clinical research expertise. The TRAC CC will provide added value by ensuring needed coordination and cross-institution communication and dissemination to create a vibrant TB clinical research environment that is truly greater than the sum of its parts and ensure a pipeline of talented NI/ESI in TB research.

摘要 – JHU TRAC 临床核心 (CC) 结核病 (TB) 仍然是一个主要的全球健康问题以及变革性的临床和转化科学 需要进行研究以有意义地改变结核病发病率、传播率、发病率和死亡率的曲线。这 约翰·霍普金斯大学 (JHU) 结核病研究中心 (CTR) 是创新和研究领域的全球领导者。 调查，正在进行的研究涵盖临床科学领域，并与 NIH 紧密结合 结核病研究的战略研究重点。然而，为了在世卫组织终止结核病目标方面取得进一步进展 为了实现这一目标，培育新的跨学科研究并促进新一代结核病研究人员和 领导人。因此，JHU TRAC 临床核心 (CC) 的首要目标是促进转型 通过提供人群接触、指导和物质支持来开展结核病临床研究 临床和转化科学研究。 CC 将增加价值并加强基础研究 建立假设、促进合作并提供资源以促进和促进 培养下一代结核病研究人员。 CC 的基础是我们广泛的患者群体 国内和国际的生物样本库，再加上技术、监管和 临床研究专业知识。 CC将通过桥接科学资源加强临床结核病研究能力 在约翰霍普金斯大学，这些机构目前因部门、物理和后勤障碍而分隔开来。为此，我们建议 首先为新老研究者之间交流研究方法和思想创造新的途径 （目标 1）。我们将参加每周结构化的 TRAC 研讨会系列，重点关注结核病研究 检测、预防、治疗和跨领域主题，以及 TRAC K-Club 和 K2R Club 以及年度 结核病科学会议和 TRAC 数据博览会。我们将为新阶段和早期阶段提供更好的机会 研究人员 (NI/ESI) 提出并接收反馈，同时加强对小说的集体理解 结核病临床科学的发展并促进跨学科指导和合作。鉴于 JHU TRAC、NI 和 ESI 的广泛研究活动将受益于协调的访问和 了解研究机会、进入国际和美国诊所、患者群体和联盟的机会，以及 样本库（目标 2）。 CC 支持的研究联络员将管理统一的可搜索 JHU TRAC 资源和研究数据库，并提供直接帮助和方法指导 NI/ESI 和学员可以链接到导师、研究机会和数据资源。我们将确保 NI/ESI 拥有成功启动和执行临床研究（目标 3）的资源，并提供共享 CC 研究协调员。学员将在监管流程管理和研究实施方面获得支持。 JHU 拥有出色的结核病临床研究专业知识。 TRAC CC 将通过确保所需的 协调和跨机构沟通和传播，打造充满活力的结核病临床研究 真正大于其各部分之和的环境，并确保 NI/ESI 在结核病研究方面的人才储备。