CTSA INFRASTRUCTURE FOR CLINICAL TRIALS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Columbia University Medical Center's (CUMC) CTSA program will transform the culture of clinical and translational (C/T) research so that we can develop and retain an outstanding cadre of senior faculty to lead the next generation of C/T investigators. With outstanding support from the CUMC - Herbert Irving Endowment, which will increase from its present level of $15 million to $25 million dollars, we will accomplish our goal by creating the Irving Institute for Clinical and Translational Research (ifCTR). The IICTR will be the academic and intellectual home for the next generation of C/T investigators. The IICTR will have an outstanding faculty of senior and junior C/T investigators who will lead Resources developed to carry out the Key Functions defined in RM-06-002. The senior faculty will provide leadership and stature for the IICTR, and serve as mentors for both the junior faculty and IICTR trainees. The junior faculty, called Irving Fellows, will be supported by CUMC funds ($450,000/y) and will work with senior faculty to develop novel approaches to breaking down the barriers to multi- and interdisciplinary (M&l) C/T research. The Irving Scholars will be role models for the way M&l research should be conducted at CUMC, and the Resources provided by IICTR, including outstanding support and research in biomedical informatics, biostatistjcal and clincal trial design, bioethics, regulatory issues, patient oriented research, and core resources, will allow us actuate those changes. The Irving Fellows will be supported by CUMC as will pilot and collaborative research grants awarded by the IICTR ($700,000/yr). The IICTR will have 35,000 sq ft of space, including 6,000 sq ft of newly constructed space for inpatient/outpatient research at CUMC ($3 million), 2,200 sq ft of new space for the Center for Clinically Oriented Research Education ($1 million) that will be a home for our trainees and faculty, and a new off-campus research center to support community-based C/T research and education ($1 million). We have created an integrated eductional program that includes a new multidisciplinary patient oriented research (MPQR) Master's degree, a novel K12 Scholars Mentored Research Program in M&l research, and a pioneering MPOR PhD program. All CTSA activities will be tracked and evaluated regularly. Pediatfic and community-based G/T research will receive special attention. The IICTR and CTSA will break down the barriers impeding movement of new knowledge from the bench to the bedside and community.