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

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There is a critical need for rapid translation of novel preclinical data into new treatments for patients with a variety of neurological diseases. The Network for Excellence in Neuroscience Clinical Trials (NEXT) was established by NINDS in 2011 with the objective to develop and conduct Phase 2 clinical trials and biomarker validation studies. Northwestern University’s (NU) Feinberg School of Medicine (NUFSM) has been an active and effective member of the consortium since inception. This application has been developed in response to the NINDS RFA to continue our participation as a Clinical Site in the NEXT. The NU NEXT Center is a collaborative effort that coordinates faculty and resources of three major NUFSM hospitals: Northwestern Memorial Hospital (NMH) with 11 hospitals in the network, Lurie Children’s Hospital (LCH) and the Shirley Ryan Ability Lab (SRALab). The NCTC faculty is comprised of highly skilled clinician investigators with expertise across all neurological subspecialties and access to a large patient base of diverse and well characterized adult and pediatric populations with a variety of neurological diseases. As we have demonstrated in the prior funding period, the NU NEXT Center is highly qualified to continue to participate in NEXT and to contribute to the development and successful completion of the network clinical trials and biomarker validation studies. The key personnel have extensive experience in clinical and translational research in their respective subspecialties; leadership roles in major research programs (including NINDS-funded projects); track record of cutting edge collaborative projects, importantly, experience in gene delivery and therapy studies; access to large and diverse populations of patients with neurological conditions; and success in enrolling patients and control participants in the NEXT and other clinical trials sponsored by NIH, private foundations and industry sources. The established infrastructures of our Northwestern University Clinical and Translational Sciences Institute (NUCATS) supported by NIH funded Clinical and Translational Science Award (CTSA) and our departmental Clinical Trials center will continue to assure timely participants recruitment by our Center. The NU NEXT Center has all required resources, facilities and equipment necessary to continue to support and actively participate in NEXT projects including pediatric population. There is a strong institutional emphasis to increase diversity of the research participants and research teams. There is extensive expertise and track record of success in training the next generation of clinician investigators. Participation in NEXT will enable the NU NEXT Center to continue to contribute expertise and research participants to neurological clinical trials across multiple subspecialties in adult and pediatric populations, consolidate efforts across disciplines, and to further expand training for junior investigators to enable them to develop independent research careers.