CTSA INFRASTRUCTURE FOR CLINICAL TRIALS

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This subproject represents an estimate of the percentage of the CTSA funding that is being utilized for a broad area of research (AIDS research, pediatric research, or clinical trials). The Total Cost listed is only an estimate of the amount of CTSA infrastructure going towards this area of research, not direct funding provided by the NCRR grant to the subproject or subproject staff. The Yale Center for Clinical Investigation (YCCI) was created to provide a "home" for training the next generation of clinical investigators. Key programmatic goals are to 1) attract highjy talented students and junior faculty across medicine, nursing, public health, biological sciences and biomedical engineering; and train them in the use of state-of-the-art research tools; give them the skills to work within complex research teams; and support their professional development; and 2) foster the translation of disease-related discoveries from the laboratory into the community by: stimulating the creation of Interdisciplinary teams; making available state-of-the-art core facilities and expanded biostatistical and bioinformatics resources; establishing organizational and regulatory infrastructure for clinical studies; and forging a dynamic new partnership that will integrate community leaders, physicians, and health centers. Participating institutions include the Schools of Medicine, Nursing, Public Health, the Department of Biomedical Engineering and Graduate Programs in Biological and Biomedical Sciences. The Investigative Medicine program (IMP) is central to YCCI's education and training efforts. It is a unique doctoral program that offers Ph.D. degrees in Health Sciences Research to highly qualified M.D. fellows embarking on careers in translational or clinical research. IMP will be expanded with CTSA support to include nursing, public health, biological sciences, and MD-PhD students. YCCI has also created a Society of YCCI Faculty Mentors who will participate actively in the training and nurturing of the students and junior faculty members identified as YCCI Clinical Scholars. Pilot and feasibility (P&F) grants will be awarded for. 1) junior faculty; 2) interdisciplinary translational teams; 3) new technologies; and 4) community-based projects. YCCI will cluster research cores around common themes, including: imaging; specimen analysis; physiology; cognition and behavior; drug development; and cell therapy. A new Office of Research Services will provide facilities for "one-stop" shopping for regulatory, biostatistical, bioinformatics, recruitment and other support services. YCCI will have an office to coordinate the University's efforts to address health issues facing our community. The University's decision to immediately provide substantial support to establish the YCCI reflects its strong commitment to an innovative redesign of our clinical and translational research activities