Clinical Core

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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.