Clinical and Translational Science Institute at Childrens National

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OVERALL: PROJECT ABSTRACT Although children comprise one-quarter of the US population, only 10% of ClinicalTrials.gov registered studies focus on child health-related clinical and translational research (CTR). The mission of the Clinical and Translational Science Institute at Children's National (CTSI-CN) is to address the barriers and serve as a hub within the CTSA Network that is focused on the promotion of child health CTR. Established in 2010, the inaugural CTSI-CN (CTSI-CN v1.0) was organized as a collaboration between Children's National Health System (CNHS) and its academic partner, The George Washington University (GW). Over the past four years, CTSI-CN v1.0 has positioned itself as an effective catalyst for child-health CTR around four major themes: 1) improving the health of children and their families; 2) developing novel treatment strategies for rare genetic diseases; 3) designing new devices for pediatric care; and 4) characterizing childhood precursors of disease along the lifespan. We have embraced many of the tenets recommended in the July 2013 Institute of Medicine (IOM) report, specifically, developing multidisciplinary teams, providing cost-effective services and support for investigators, and streamlining processes that impact the effective conduct of CTR. The CTSI-CN is acknowledged locally as the hub for effective, high quality child health CTR and as a nurturing, integrated home for CTR team science. Nationally, the CTSI-CN has provided leadership in child health CTR, in both CTSA- and non-CTSA-linked consortia and steering committees. In the current proposal (CTSI-CN v2.0), we will continue to advance our vision and mission through innovative approaches and enhanced capabilities in our strategic themes. To this end, we have expanded our partnership to include Virginia Tech (VT) and its clinical partner, the Carilion Clinic. The goals of CTSI-CN v2.0, which will build on our established strengths, the lessons learned in CTSI-CN v1.0, and our new partnership with VT/Carilion (VTC), will also address the four NCATS strategic themes by: 1) developing a new generation of diverse, high quality child health-focused CTR investigators through innovative, inter-institutional educational, training, and mentoring programs (WORKFORCE DEVELOPMENT); 2) creating innovative approaches and technologies to catalyze CTR, particularly in child-health, through novel cross-disciplinary and inter-institutional collaborations with multiple stakeholder communities (COLLABORATION AND ENGAGEMENT); 3) catalyzing the development, dissemination and evaluation of novel methods to enhance translational science, with a particular emphasis on the child-health CTR spectrum (METHODS AND PROCESSES); 4) enhancing quality and efficiency across the translational spectrum through a) the integration of a high quality diverse workforce, b) implementation of new methods and processes, and c) collaboration among the institutional partners and communities (INTEGRATION): and 5) providing leadership within the CTSA Network through multi-site collaborations and educational programs, with a particular emphasis on child-health CTR and outcomes (CTSA NETWORK).