State University of New York (SUNY) Downstate NETT Clinical Site Hub

DESCRIPTION (provided by applicant): The State University of New York (SUNY) Downstate Medical Center has created a Clinical Site Hub and Spoke NETT to join a national clinical research network. Our 5-hospital NETT, included within federally designated underserved areas, serves a large minority population, will conduct clinical trials designed to develop effective treatments for patients with neurological emergencies. Our existing infrastructure of the Hub at SUNY Downstate Medical Center, with joint experienced leadership from Emergency Medicine and Neurology, has established 2 large spokes: Lincoln Hospital (south Bronx), serving primarily Hispanics, and Maimonides Medical Center (Brooklyn), one of the largest independent teaching hospitals in the US. We work collaboratively with investigators and clinicians in critical care, neurosurgery, Trauma, Stroke, and Epilepsy Centers, Neuroradiology, Rehabilitation, Community Engagement/ Disparities Research, Fire Department of New York (FDNY) Pre-Hospital 911 System, Pharmacy, and Information Technology. Our goal is to identify, recruit, and retain a large number of participants from highly diverse backgrounds in high quality clinical research in neurological emergencies using best research practices and the highest ethical standards of research conduct. We will facilitate the transfer of research results to clinical practice via active dissemination of study findings. We are mentoring junior faculty, including minority investigators, in the conduct of phase 3 randomized clinical trials. Our growing infrastructure includes a recently NINDS-funded SUNY NeuroNEXT UIO for phase 2 trials among other formalized and funded research and training programs. This NETT is jointly led by experienced clinical trialists well-versed in complex multi-center administrative structure and projects with established mentoring programs and a growing cadre of acute neurology subspecialists. Our NETT includes a combined annual ED volume of over 350,000 visits, with over 3,500 neurological emergencies. Strengths include the extremely diverse, large patient pool, extensive NIH clinical trials experience, detailed ED visit data from all hospitals, acute telemedicine experience, expertise in exemption from informed consent, and well-established, extensive community networks and engagement. PUBLIC HEALTH RELEVANCE: Neurological Emergencies are a major cause of morbidity and mortality in the US and are extremely costly illnesses. There is a great need to develop proven treatments for these conditions. There is also a disproportionate risk and burden on underrepresented minorities (URM) for many types of neurological emergencies which our NETT Clinical Hub Site and Spokes has been focusing on for recruitment. We also will train UBM investigator's in the conduct of clinical trials.