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

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DESCRIPTION (provided by applicant): 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. The aims of the proposed NINDS Network of Excellence in Neuroscience Trials at the University of Pittsburgh (NEXT-UP) are: (1) to develop an administrative structure to rapidly implement NEXT trials across of wide range of neurological conditions; (2) to foster collaboration and outreach in NEXT trials among community physicians, patients and patient support groups; and (3) to promote careers in clinical trial research by integrating training with NEXT-UP activities. The NEXT-UP leadership plan reflects these goals with a Program Director (Lawrence R. Wechsler, MD) and co-Program Director; an Advisory Committee with an adult neurologist, pediatric neurologist, neurosurgeon and rotating member with trial-specific expertise; and a Program Coordinator. Collaboration will be established by meeting regularly and feedback sessions. Recruitment will occur through high-volume referral providers, active surveillance and community outreach. Outreach includes the NEXT-UP Academy, registry, website and Study Partner Program. Efficiency and monitoring will be accomplished through: a tier-1 federated IRB model; 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 involving all career levels including: NEXT-UP workshops, a NEXT-UP elective, and hands on-experience implementing a NEXT trial with a more senior co-investigator. The combination of the University of Pittsburgh Medical Center's regional dominance in healthcare and this innovative proposal will allow NEXT-UP to become a model site in the NEXT network with efficiently run clinical trials integrating investigators with community providers, patients and trainees.