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 develop an administrative structure to rapidly implement NeuroNEXT trials across of 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. The NEXT-UP leadership plan reflects these goals with a Program Director (Paula R. Clemens, MD) and co-Program Director (Lawrence R. Wechsler, MD); an Advisory Committee 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 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.
The Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT) at the University of Pittsburgh (NEXT- UP) will continue to leverage the regional dominance of UPMC in healthcare, the CTSI, existing clinical research networks at the University of Pittsburgh, and other institutional resources for its successful clinical trials structure. NEXT-UP will continue to engage in practices that have led to successful enrollment into studies and will work to further increase capacity for entering patients into trials, as well as contribute to the educational, collaborative, and administrative functions of the overall network. NEXT-UP will actively support career development for early stage academic clinician researchers in neuroscience.
