University of Pennsylvania Center for the Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT)

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The goal of the proposed Penn Center for Excellence in Neuroscience Clinical Trials (Penn NeuroNEXT) is to bring together and optimize the contributions of a large group of experienced investigators focused in the clinical neurosciences at the University of Pennsylvania Perelman School of Medicine (UPennSOM), across four major teaching hospitals: the Hospital of the University of Pennsylvania (HUP), the Children's Hospital of Philadelphia (CHOP), Pennsylvania Hospital (PAH) and Penn Presbyterian Medical Center (PPMC). UPennSOM has long been a leading Center for clinical research in the neurosciences, and internationally recognized leaders in neurology, neurosurgery, neuroradiology, and psychiatry have a strong track record of collaboration, evidenced by existing multiple program projects, collaborative agreements, successful participation in federally and industry-sponsored multi-center clinical trials, and a large number of investigator- initiated studies. The expertise of Penn NeuroNEXT investigators covers the lifespan, and they have been leading contributors to our understanding of and development of innovative therapies for neurological disorders from infancy through old age. Penn NeuroNEXT will leverage existing clinical research infrastructure and resources to efficiently Penn NeuroNEXT will contribute to NeuroNEXT by leveraging the expertise of senior leaders in the clinical neurosciences at Penn, as well as the enthusiasm and hard work from a large number of ambitious trainees and junior faculty. These goals are operationalized through the following three Specific Aims: Specific Aim 1: To be an outstanding enrolling site for NeuroNEXT trials. Penn NeuroNEXT will participate in a minimum of 4 NeuroNEXT clinical trials over the next 5 years. We intend to meet or exceed recruitment and retention goals. Specific Aim 2: To optimize efficiency of clinical research in neurosciences at UPennSOM. Penn NeuroNEXT will closely monitor progress of all NeuroNEXT trials, from site qualification, IRB submission, staff training, participant recruitment and retention, data quality assessment, and study closeout. Barriers to success will be identified early, and the experience and institutional influence of Penn NeuroNEXT leadership will be leveraged to overcome such barriers. We will insure that all ancillary services needed for successful participation in Network trials are available for each trial. These include the Investigational Drug Service (IDS), Center for Clinical Epidemiology and Biostatistics, Neuroradiology, Pathology and Laboratory Medicine. Specific Aim 3: To promote career enhancement of early stage clinical investigators. The University of Pennsylvania and our four hospitals are recognized as leading training centers in the clinical neurosciences, and we have been particularly successful in attracting talented young people interested in obtaining the necessary experience for launching academic careers.