CTSA Supplement

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Contact PD/PI: Brasier, Allan R. The CTSA at the University of Texas Medical Branch (UTMB) is located within the Institute for Translational Science (ITS), one of three free-standing UTMB institutes, established in 2007. In its role as the home for clinical and translational research, the ITS provides primary tenure-earning faculty appointments to 7 early- career translational scientists. Over the past 5½ years, we have transformed UTMB's research culture, growing from an institution that solely valued individual laboratory-oriented research to one that embraces multidisciplinary translational team (MTT) approaches to addressing significant health problems. We have developed novel educational curricula, significant clinical research programs in special populations with multi- site clinical trials (CTs), and provided leadership in the Texas Regional CTSA consortium (TRCC) and nationally. The mission of the UTMB CTSA hub is to support the health goals of the nation by generating, testing and disseminating integrative team science, education and best practices through stakeholder involvement at all stages. Managed by a continuous improvement model using an Innovation Scorecard, the UTMB CTSA will address four specific aims, to: 1) Train a diverse workforce in the authentic skills needed to advance all phases of translational research. We have used the team environment as an educational framework to support the training of diverse learning communities. Our innovation, entrepreneurship, and team leadership curricula will be used to instill focused, career stage-appropriate competencies in our trainees. We have led in sharing and disseminating innovative educational content in entrepreneurship and team science throughout the consortium. 2). Engage stakeholders across all phases of translational research and CTs. We will extend our substantial bidirectional interactions with stakeholders from the community, patient advocacy groups, healthcare providers and our Health System to assess health needs, set CTSA priorities and disseminate competencies. 3). Integrate quality systems through all types of translational research, including CTs in special populations. We have provided leadership to a university-wide plan for sustainable support for high-quality CTs through the Office of Clinical Research, supported by an experienced director, an interoperable Clinical Trial Management System and staff to provide streamlined support for all phases of CT start-up, quality assurance monitoring, study management and GCP training. 4). Advance the conduct of translational research through MTT-based innovation. The UTMB CTSA hub is unique in the national consortium in its systematic application of a hybrid industry-academic MTT model, and have developed an evidence base on the formation, evaluation, impact and trajectories of successful MTTs. We will stimulate MTT innovation by promoting team development, leadership development by a unique Leadership Development Academy, and advancement of therapeutics and devices into Phase I/II CTs in our “Innovations in Molecular Therapeutics and Devices” Optional Module. Project Summary/Abstract Page 308 Contact PD/PI: Brasier, Allan R. Narrative The UTMB CTSA hub will support bidirectional translational research, moving discoveries from the bench to the bedside, by training a capable workforce using our unique multidisciplinary translational teams and innovative educational programs that build real-world skills. Our hub will serve to foster high-quality clinical research, develop best practices in team-based translations, participate in inter-institutional data-sharing, and function as an efficient site for multi-site clinical trials in understudied populations. In this manner, the UTMB CTSA hub will be an important contributor to achieving the goals of the national consortium.