This application from the State University of New York (SUNY) responds to the NINDS RFA to participate as a Clinical Site in the Network for Excellence in Neuroscience Clinical Trials (NEXT). We have brought together the 4 SUNY Academic Health Centers (AHCs), their local, diverse communities, and their liaisons with hospital (including 4 children's hospitals) and clinic networks, large referral bases and patient volumes, and industry. This will insure a robust and accessible infrastructure to facilitate rapid developmental and implementation of protocols for adults and children to be recruited into neurological clinical trials throughout NY state. By combing 4 SUNY campuses into one application, we have created a highly innovative and considerable network of patients with extremely diverse ethnic and racial backgrounds combined with vast breadth and depth of faculty (over 100) disease subspecialization and expertise. Approximately 42% of the state's population lives within the counties/boroughs serves by this SUNY NEXT application. The SUNY NEXT is therefore in a position to shift performance models and improve public health on a faster timeline because of the size of the referral and catchment area and generalizability of the diverse patients seen. Momentum for highly successful SUNY cross-campus projects has increased dramatically in the past 8 years with key leadership forming and supporting the formation of SUNY Research Excellence in Academic Health (REACH) via institutional hard dollars and grants. This SUNY NEXT proposal will further enhance infrastructure and expand our multi-campus Clinical Trials Network that currently includes a U10 SUNY NEXT, U10 NETT Hub, U10 StrokeNET sites, U24 SIREN SubHub, and now a CTSA. Our experience includes over neurology 100 trials in the past 8+ years. We have built this network and continue to refine it to provide a comprehensive array of disease-specific expertise (adults and pediatric neurologic specialists/subspecialists), clinical trial expertise and experience including trial coordinators, clinical/ translational research infrastructure, institutional commitment, and ongoing/expanding community-based input and research. Our network can coordinate a large, geographically diverse cadre of disease-based investigators to implement studies efficiently in response to disease-specific opportunities (MTAs and cIRB use already in place), supported by SUNY NEXT currently in the top 1/3 (8th of 25) of NEXT sites for recruitment and retention with outstanding data quality. We also have a group of early stage investigators (ESIs), including under-represented minority investigators, who we will train and mentor in trials (including SUNY-wide video subspecialty telementoring) and who will compete for a yearly slot that protects time with funded salary support. We will explore, given our expertise and connectivity in telemedicine, the feasibility of performing trials to more remote, smaller sites affiliated with SUNY NEXT to gain even greater representation of rural Americans into trials. Our success will shift paradigms for collaborative structuring of trials and ultimately improve public health.
The burden of neurological disease is great, estimated at $800 billion annually in the United States. Treatments are needed to reduce morbidity and mortality. We propose a 4 campus network combining breadth and depth of neurological expertise, faculty, and diverse patient populations to test new treatments in a large NINDS multi-center consortium.
