NORTH AND CENTRAL TEXAS CTSA 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. We propose to establish a North and Central Texas Clinical and Translational Science Initiative (NCTCTSI), which will be led by the University of Texas Southwestern Medical School at Dallas and will include many of the nation's leading schools of allopathic and osteopathic medicine, dentistry, nursing, pharmacy, public health, engineering and computer science - which have already formed a highly functional relationship supported by a Road map K12 award. We have established a Department of Clinical Sciences, which is supported by faculty from all participating schools and which will serve as the academic home for our CTSA. The Department provides academic appointments to clinical and translational investigators and to faculty whose expertise and research is focused on methodological disciplines common to all clinical research - in order to promote 'multidisciplinary team building and problem solving. The NCTCTSI will build on existing nationally- recognized programs supported by K30, M01 and Roadmap K12 awards and will integrate numerous institutional strengths to offer 12 highly innovative and fully integrated key functions: (1) building a unique academic home for clinical and translational research; (2) transforming a culture: investigator development and recognition; (3) research education, training and career development; (4) biomedical informatics; (5) stimulating novel translational ideas and methodologies; (6) support for pilot and collaborative studies; (7) research study development: design, statistics and ethics; (8) scientific review and evaluation; (9) regulatory knowledge and support; (10) participant and clinical interactions resources; (11) community engagement; and (12) translational technologies and resources. Particular strengths are: (1) a substantial financial commitment of participating institutions to the Initiative; (2) an established academic and cultural home that currently addresses many of the goals of the NIH; (3) > 200 established clinical and translational investigators who will act as faculty and mentors; (4) a highly innovative approach to integrating key functions that will act to create bonds among the members of a multidisciplinary academic community; (5) a large and medically diverse patient base cared for by internationally-renowned hospitals (which are strong supporters of this initiative); (6) > $150 million in annual peer-reviewed grant support for clinical studies; (7) superb infrastructure to support clinical and translational research; and (8) program leadership with the time, experience and commitment to ensure the success of the Initiative. The coordinated synthesis of these strengths will allow the NCTCTSI to improve the health of our community and to contribute to the national CTSA consortium and thus help to identify best practices that will benefit clinical and translational research throughout the nation.