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. This application is for an ICTSA to be established at the University of Texas Medical Branch at Galveston (UTMB). Our rationale is that UTMB brings depth to the CTSA consortium, because: we are the only academic health center with both an NIAID-funded Regional Center for Excellence in Biodefense and a National Biocontainment Laboratory; we are the only center with two NIH-funded translationally oriented proteomics centers in biomarker research; we have developed translational research programs with three national laboratories (the Galveston and Sandia National Laboratories and NASA); we have trained more underrepresented minority MDs than any non-historically Black institution in the US; we have the only approved PhD-awarding Clinical Science Training program in a public university in Texas; and we have the largest telemedicine operation in the world. In response to Hurricane Ike, we have established a richer outpatient clinical research network in South East Texas. Our ICTSA are to: 1. Facilitate translational research as a rigorous discipline; 2. Develop translational research training programs at all levels in the graduate continuum; 3. Effectively conduct and bridge step 1 translational research (Tl) to steps 2 (T2) and -3 (T3); and 4. Interface productively with the national CTSA Consortium. To accomplish these goals, we have organized our ICTSA into 12 "Key Resources" ~ combinations of university core laboratories and intellectual resources, integrated by a single point of investigator/trainee contact. This structure will make us more rapidly responsive to the needs of our investigators and trainees. In this application, our Key Resources are assembled to support the translational goals of exemplar multidisciplinary translational teams (MTTs), generally organized around our successful NIH- funded interdisciplinary research centers. Three overlying principles will guide our ICTSA's operations, to: 1. Employ proactive mechanisms in identifying new team-oriented research opportunities; 2. Prioritize trainee involvement in a team-based culture; and 3. Integrate systems biological approaches into translational research. UTMB's senior leadership is providing significant new institutional resources, including establishing the Institute for Translational Sciences (ITS), our new home for translational research; new commitments of pilot grant support; administrative support; and support for a significant expansion of bioinformatics faculty. The ITS Director reports directly to UTMB's Provost, who is responsible for integration of research and education university-wide. We are thus well-positioned to achieve our goals, significantly transform clinical and translational research at UTMB, and contribute to the national CTSA Consortium. RELEVANCE (See instructions): The ICTSA will allow our researchers to more quickly and effectively translate basic science discoveries into improvements in human health. In particular this award will allow us to build teams of researchers with diverse skills who can work effectively towards a health outcome-related goal. In this way the ICTSA will break down communication, technology and regulatory barriers and transform how our university conducts patient-oriented research.