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. The network has been highly successful. The Neurology Clinical Trials Center (NCTC) at Northwestern University's (NU) Feinberg School of Medicine (NUFSM) has been an active and effective member of the consortium. This application has been developed in response to the NINDS RFA to continue our participation as a Clinical Site in the NEXT. The NU NCTC is a collaborative effort that coordinates faculty and resources of three major NUFSM hospitals: Northwestern Memorial Hospital (NMH), Lurie Children's Hospital of Chicago (LCH) and the Shirley Ryan AbilityLab (SRALab), formerly Rehabilitation Institute of Chicago (RIC). 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 initial funding period, the NU NCTC 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; access to large and diverse populations of patients with neurological conditions; and success in enrolling patients and control subjects 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 NCTC will continue to assure timely subject recruitment by our Center. The NU NCTC has all required resources, facilities and equipment necessary to continue to support NEXT projects. In addition, there is substantial expertise at NU that has grown substantially since the original submission in the design and execution of translational studies for future NEXT projects. Participation in NEXT will allow NCTC to contribute to the neurological clinical trials across the subspecialties in adult and pediatric population, consolidate the effort across the divisions and provide training for the junior investigators that will enable them to develop independent research careers.
This application has been developed in response to the NINDS RFA to renew our participation as a Clinical Site in the Network for Excellence in Neuroscience Clinical Trials (NEXT). Participation in NEXT will enable Northwestern University to contribute expertise and research subjects to neurological clinical trials across multiple subspecialties in adult and pediatric populations through its three major affiliated clinical facilities: Northwestern Memorial Hospital (NMH), Ann & Robert H. Lurie Children's Hospital of Chicago (LCH), and the Shirley Ryan Ability Lab (SRALab).
