Network of Excellence in Neuroscience Clinical Trials (University of Pittsburgh CRS)

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To translate the rapid progress in neurological therapeutic developments to patient care, clinical trials must keep pace with preclinical discoveries. Hurdles encountered in neuroscience clinical trials include delays in regulatory approvals, slow recruitment, participants lost to follow-up and slow translation of findings to clinical practice. The University of Pittsburgh has unique and significant resources and a proven track record of excellent performance in clinical trials, and in NeuroNEXT in particular. The aims of the proposed NINDS Network of Excellence in Neuroscience Trials at the University of Pittsburgh (NEXT-UP) are: (1) to continue and enhance an effective administrative structure with the capacity to rapidly implement NeuroNEXT trials across the wide range of neurological conditions; (2) to foster collaboration and outreach in NeuroNEXT trials among academic physicians, community physicians, patients and patient support groups; and (3) to promote careers in clinical trial research by integrating clinical research training of early-stage investigators with NEXT- UP activities and pair them with effective mentoring. The NEXT-UP leadership plan reflects these goals with a Program Director (Paula R. Clemens, MD); an Advisory Board incorporating expertise and liaison to adult and pediatric neurology clinicians and patients; an early stage investigator; and a Program Coordinator. Collaboration will be established by meeting regularly and outreach to providers and the community. Recruitment will occur through high-volume referral providers and community outreach. Efficiency and monitoring will be accomplished through use of a central IRB and standardized trial agreements; establishing a timeline and benchmarks for each trial; monthly reports to the NEXT-UP Leadership from co-Investigators; and Corrective Action plans for challenges encountered. Promotion of careers in clinical trial research will include a training plan for early stage clinical neuroscience investigators. The combination of the University of Pittsburgh Medical Center’s regional dominance in healthcare, resources from the Clinical and Translational Science Institute (CTSI) at the University of Pittsburgh and this innovative proposal will allow NEXT-UP to continue to be a model site in the NeuroNEXT network with efficiently run clinical trials integrating investigators with community providers, patients and trainees.