UTSW Clinical Research Site for Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT)

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This is an application for competitive renewal of UT Southwestern Medical Center (UTSW) as a clinical research site for the Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT). The project continues to be led by Drs. Mark Goldberg and Susan Iannaccone, who bring experience in program leadership with complementary areas of expertise in adult and pediatric neurology, respectively. The project has demonstrated enrollment and operational successes in the initial funding period. UTSW is one of the few sites selected to participate in all eight funded studies by the network (NN109 site selection is still underway). We are among the top five enrolling sites and have met or exceeded network averages for patient recruitment, retention, timeliness, data quality and accuracy metrics. We propose to expand on these successes in the next cycle. First, we will take advantage of new institutional relationships to expand the number of patients available for screening and enrollment. UTSW has partnered with a large health network, Texas Health Resources, to create an integrated health system of 31 hospitals and clinics called the Southwestern Health Resources (SWHR). Altogether, our collaborative research relationships with community care partners and health systems brings potential enrollment access to almost three quarters of the Dallas-Fort Worth metroplex. In addition, the newly formed Peter O’Donnell Jr. Brain Institute at UTSW brings together several departments and centers focused on the study of the nervous system under a multi-disciplinary, collaborative umbrella. Second, we will make use of innovative research resources to improve the speed, efficiency, and quality of clinical trials. With the initial launch of NeuroNEXT, we established the Neuroscience Translational Research Center (NTRC), which provides core services, dedicated research space, equipment, regulatory expertise, and trained personnel for NIH and other studies across the clinical neurosciences. This resource has grown in scope and quality, and will be further enhanced with improved database support, an expanded institutional EMR-to-research data warehouse, and new online tools for patient recruitment and enrolment. Third, we will implement a clinical research curriculum, taking advantage of existing resources for early stage investigators (ESI) in collaboration with the Center for Translational Medicine (CTM) at UTSW. We have had ESIs serve as study PIs on six of the eight NeuroNEXT studies, proving our commitment to early career development. We will continue provide structured curriculum with clinical research mentorship to several candidates from our talented pool of ESIs.