Core-005

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The Michigan Institute for Clinical & Health Research (MICHR) proposes the development of a new institutional infrastructure—the University of Michigan (U-M) Clinical Research Network—comprised of trans-departmental Clinical Research Service Units that focus initially on the efficient conduct of high-quality clinical trials of all phases. MICHR will lead this initiative across all seven health science schools of U-M. The systematic and comprehensive nature of this transformation will enable us to embed and test many new processes aimed at enhancing quality, lowering barriers to engaging special populations, and accelerating discoveries across the translational continuum. Our long-term goal is to develop, demonstrate, and disseminate best practices for expanding hub research capacity. In order to fulfill this objective, we will systematically implement a series of processes and procedures that we hypothesize will enhance the quality and efficiency of our local research infrastructure, allowing us to achieve connectivity and integration across multiple research and community units. We will achieve these objectives by pursuing the following specific aims: 1) Improve the hub research capacity of U-M through the enterprise-wide implementation of a trans-departmental Clinical Research Service Unit infrastructure; 2) Reduce the barriers to clinical-translational research in children by improving informed consent and enhancing both local and national clinical trial infrastructure for the pediatric population; 3) Reduce the barriers to clinical-translational research with older adults by integrating and advancing geriatric research infrastructure. We expect that expanding hub research capacity through a comprehensive transformation with an initial focus on the clinical trial enterprise will achieve greater trial quality and efficiency, while establishing a platform that will allow us to improve all clinical and translational research at U-M. Process changes will be tracked carefully, enabling us to identify best practices and lessons learned that could be disseminated throughout the CTSA network and beyond. Furthermore, we expect to increase the participation of special populations across the lifespan in clinical and translational research.