Clinical Core

JHU TRAC临床核心(CC) 结核病(TB)仍然是一个重大的全球健康问题和变革性的临床和翻译科学。 需要进行研究，使结核病的发病率、传播率、发病率和死亡率曲线有意义地弯曲。这个 约翰霍普金斯大学(JHU)结核病研究中心(CTR)是全球创新和 调查，目前正在进行的研究跨越临床科学的范围，并与美国国立卫生研究院紧密结合 结核病研究的战略研究重点。然而，为了在世卫组织结束结核病的目标上取得进一步进展 为了实现这些目标，关键是要促进新的跨学科研究，促进新一代结核病研究人员和 领袖们。因此，JHU TRAC临床核心(CC)的总体目标是促进 通过提供接触人群、指导和开展结核病临床研究的物质支持 临床和转化科学研究。CC将增加价值并加强基本研究 基础设施，以制定假设，促进协作，并使资源可用来促进和 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 和生物质谱库，再加上深入的技术、监管和 临床研究方面的专长。CC将通过连接科学资源来加强临床结核病研究能力 在JHU，目前被部门、物理和后勤障碍隔开。为此，我们建议 第一，为新老研究人员之间交流研究方法和思想创造新的途径 (目标1)。我们将参加每周一次的TRAC系列研讨会，重点是结核病的研究 检测、预防、治疗和交叉专题，以及TRAC K-Club和K2R Club，以及年度 结核病科学会议和TRAC数据交易会。我们将为新阶段和早期阶段提供更好的机会 调查人员(NI/ESI)提供和接收反馈，同时加强对小说的集体理解 促进结核病临床科学的发展，促进跨学科的指导和合作。给定 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、接触国际和美国诊所、患者队列和财团，以及 标本储存库(目标2)。CC支持的研究联络人将管理整合的可搜索内容 JHU TRAC资源和研究数据库，并为以下方面提供直接援助和方法指导 NI/ESI和受训人员，用于链接到导师、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。受训人员将在管理法规程序和研究实施方面得到支持。 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，创造充满活力的结核病临床研究 这是一个真正大于其各部分之和的环境，并确保在结核病研究方面有一条有才华的NI/ESI管道。

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.