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 Rockefeller University Hospital, a GCRC awardee since 1963, has been the continuous "home" for clinical and translational science at Rockefeller since 1910. It has been the site of numerous landmark scientific and clinical contributions, and many of its trainees have gone on to become academic leaders. With the new resources available under a Clinical and Translational Science Award (CTSA), a core faculty of. distinguished investigators, whose research spans the basic-translational spectrum and encompasses a broad range of scientific and medical disciplines, will integrate and expand their scientific and educational programs in a new Rockefeller University Center for Clinical and Translational Science. The new Center will transform clinical and translational research by encouraging new studies, and by enhancing and centralizing the support structures required to conduct studies with scientific rigor and an absolute commitment to protection of human subjects and participant safety. The key elements in the transformation will be: 1) A new governance structure reflecting the NIH cooperative agreement (U54) "assistance" mechanism, 2) Creation of a new K-12 Clinical Research Scholars Program offering Masters and PhD level degrees to complement the current Clinical Scholars,Program, 3) Infrastructure enhancements to facilitate the development and conduct of clinical protocols under the principle of Good Clinical Practice (GCP), including biomedical informatics, biostatistics. bionutrition, research nursing, research pharmacy, participant recruitment and community engagement, and regulatory support and oversight from the clinical research (research subject advocate) support office, 4) Development of innovative and novel core methodologies related to dendritic cell therapy; hepatitis C, and malignancies; genetics/genomics; assessing the immune response; and metabolic phenotyping. The Center will continue Rockefeller's tradition of focusing on the interface between scientific discovery, human pathophysiology, and novel diagnostic, preventive and therapeutic strategies. It will partner with industry, when mutually beneficial, to achieve these goals. The Center will also be an active member of the National CTSA Consortium, offering the Consortium novel ideas and tools for conducting and evaluating clinical and translational research. It will also eagerly adopt the best practices identified by the Consortium and adhere to the standards set by the Consortium.