This application from the BNI (BNI) responds to the NINDS PA to participate as a Clinical Site in the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT). We have brought together the all clinical and research divisions of the departments of neurology from the BNI Saint Joseph?s Hospital and the BNI at Phoenix Children?s Hospital (PCH) their local and diverse communities, and their liaisons with industry and hospital and clinic networks. This will insure a robust and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and pediatric populations. By combining the BNI and PCH campuses into one application, we have created an innovative and very large network of patients with extremely diverse ethnic and racial backgrounds that will facilitate a sustained and powerful influence on neurological clinical trial performance leading to a faster pipeline to phase 3trials. Momentum for successful implementation of NeuroNEXT projects has increased dramatically over the past several years with key leadership forming and the hiring of respected division chiefs. There is now significant support and collaborative activities for neurological diseases within BNI and this NeuroNEXT proposal will further enhance infrastructure and expand our BNI and PCH Clinical Trials Network. We have built this network and continue to refine it to provide a comprehensive array of disease- specific expertise (adult and pediatric neurologic specialists and subspecialists), clinical trial expertise and experience including trial coordinators, clinical/translational research infrastructure, institutional commitment, and ongoing/expanding community-based advice and research. Our network can coordinate a large, geographically diverse cadre of specialist investigators to implement studies efficiently in response to disease-specific opportunities. We also have a group of junior/new clinical trialists, who we will train in the performance of neurology clinical trials. Our success will shift paradigms for collaborative structuring of clinical trials and ultimately improve public health. We also have unique programs to offer to the consortium. The BNI Outcomes and Monitoring Centers will be available for consultation, outcomes development and training, and clinical monitoring to assist any new project as desired. In addition, our tissue and fluid repositories already receive samples from centers nationwide and can be used for new NeuroNEXT projects. Finally, our expertise in biomarker development is available to any prospective investigator developing a new project.
The burden of neurological disease is great and treatments are needed to reduce morbidity and mortality. We propose a two campus network combining breadth and depth of neurological expertise to test new treatments in a large NINDS multi-center consortium. We bring many experienced clinical trialists with vast experience across a variety of neurological disciplines as well as a highly diverse patient population.
