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. The University of Rochester Clinical and Translational Science Institute (UR CTSI) will be created as the academic home for clinical and translational science, providing a centralized, integrated infrastructure. Under a system of governance in which the UR CTSI Program Director has authority over space, faculty, budgets, and other resources related to the CTSI, and in which much of the current GCRC budget is distributed to CTSI Key Functions in support of these functions, we plan to transform the two distinct research fields of clinical and translational science into a single new discipline. The goals of this discipline nclude the creation of new knowledge and techniques to diagnose, prevent and treat human disease, and he establishment of an environment that catalyzes their application to clinical practice in the community. To achieve these goals, we propose specific aims involving: novel methodologies; pilot studies; upgraded biomedical informatics, epidemiology, research design, ethics, and regulatory support; community engagement; new technology and resource cores; new educational and training programs; an Upstate New York Consortium; and rigorous evaluation and measurement of performance outcomes. Strategic planning for the UR CTSI has been underway for several years prior to this RFA. Evidence of institutional support includes commitment to a new 150,000 sq. ft. Clinical and Translational Science Building (CTSB) in which faculty conducting clinical and translational research will be brought together with students and trainees in existing and new degree-granting programs, with supporting regulatory and administrative functions, and with faculty working in collaborative disciplines such as biostatistics, epidemiology, and biomedical nformatics. The Director and Co-Directors of the UR CTSI will integrate the clinical and translational science functions contained in the CTSB with those functions located at other campus locations, such as functional genomics, other translational resources, and the General Clinical Research Center (GCRC). As an integral part of the CTSI, the GCRC will move into a newly-renovated 10,500 sq ft facility across the street from the CTSB, with enhanced functionality and subject access. As well, the UR CTSI will create two-way synergies with local community groups (school system, faith community, business, foundations) and with other Upstate New York institutions. Further, the UR CTSI will enable the sharing of data across disciplines and across institutions while assuring the privacy and confidentiality of human subjects. In summary, by coalescing and integrating new facilities with enhanced infrastructure, community and state-wide partnerships, a strong foundation of existing research and training, and a fundamentally reorganized administrative structure, the CTSI will transform the conduct of clinical and translational science at UR and contribute nationally to the forging of this new discipline.