Clinical Core

摘要- 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转化科学 需要进行研究，以使结核病发病率、传播率、发病率和死亡率的曲线发生有意义的弯曲。的 约翰霍普金斯大学（JHU）结核病研究中心（CTR）是创新和 调查，与正在进行的研究，跨越临床科学的频谱，并与NIH强烈一致 结核病研究的战略研究重点。然而，为了在世卫组织消除结核病方面取得进一步进展， 为了实现这些目标，必须促进新的跨学科研究，培养新一代结核病研究人员， 领导人的人选信号因此，JHU TRAC临床核心（CC）的总体目标是促进转型 结核病临床研究通过提供接触人群、指导和物质支持的方式进行 临床和转化科学研究。CC将增加价值并增强基本研究 基础设施，以发展假设，促进合作，并使资源可用于促进和 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 和生物标本库，再加上深度的技术，监管， 临床研究专长。该委员会将通过整合科学资源来加强结核病临床研究能力 在JHU，目前被部门，物理和后勤障碍分开。为此，我们建议 首先为新老研究者之间的研究方法和思想交流创造新的途径 (Aim 1）。我们将参加结构化的每周TRAC研讨会系列，重点是结核病研究 检测、预防、治疗和跨领域专题，以及TRAC知识俱乐部和知识对知识俱乐部， 结核病科学会议和TRAC数据博览会。我们将为新的和早期阶段提供更好的机会 研究者（NI/ESI）提出并接受反馈，同时加强对新的 结核病临床科学的发展和促进跨学科的指导和合作。鉴于 JHU TRAC、NI和ESI的广泛研究活动将受益于协调的访问， 研究机会的知识，进入国际和美国诊所，患者队列和财团，以及 标本存放处（目标2）。CC支持的研究联络员将管理一个统一的可搜索的 JHU TRAC资源和研究数据库，并提供直接援助和方法指导， NI/ESI和学员链接到导师，研究机会和数据资源。我们将确保NI/ESI 拥有资源，成功启动和执行临床研究（目标3），并提供共享CC 研究协调员。培训生将在监管流程管理和研究实施方面得到支持。 JHU拥有卓越的结核病临床研究专长。核心预算资源调拨目标协调委员会将通过确保所需的 协调以及跨机构沟通和传播，以创建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，并确保结核病研究领域有才华的NI/ESI的管道。

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.