Ohio Valley Regional Coordinating Center for NINDS Stroke Trial Network - SPECIFIC AIMS The NIH StrokeNET aims “to harness the leadership and experience of the stroke research field to maximize efficiencies for developing, promoting, and conducting high-quality, multi-site clinical trials focused on promising interventions for stroke prevention, treatment, and recovery.” (PAR-17-276) The Ohio Valley Regional Coordinating Center (RCC; formerly Cincinnati RCC) is composed of University of Cincinnati (UC) and its 33 performance sites, including academic and private comprehensive and primary stroke centers, a mobile stroke unit, and pediatric and rehabilitation hospitals, all staffed by the UC Stroke Team using a hub/spoke model. Together, we engage in a broad range of stroke research from acute treatment to secondary prevention to recovery/rehabilitation in both adults and children. Further, our network consists of one satellite, Ohio State University (OSU) with 6 clinical performances sites, including primary/comprehensive stroke centers, a mobile stroke unit, and a pediatric hospital. Key components of our RCC’s success have included: (1) Our collaborative research program. UC’s multidisciplinary stroke team, comprised of specialists in stroke neurology, neurosurgery, emergency medicine, neurocritical care, nursing, pharmacy, rehabilitation, and neuroimaging, has been strongly committed to research since the 1980s when research was embedded into our clinical operations. Since the 1980’s we have fostered a strong relationship regarding research and clinical relationship with our regional partners, recently strengthened by our research reliance agreements. Our 31 research coordinators have over 230 years of collective experience in epidemiological, acute and non-acute ischemic and hemorrhagic stroke studies. Our partnership with OSU furthers our mission of providing cutting edge stroke research to patients in the region as reflected in our new RCC name and roles. (2) Our leadership. Our team includes internationally renowned trialists, study coordinators, and scientists. We have contributed to NIH StrokeNet and informed the stroke field at-large by leading treatment trials as national/international PIs of both NIH and industry (IMS I/II/III, CLEAR/-ER/-FDR, STOP IT, PRISMS, BEST-II; and ongoing MOST, FASTEST, VERIFY, ENDOLOW)1-7 and large-scale, observational studies (GERFHS, GCNKSS, ERICH, FIA I/II, ROSE, ROSELAWN, BEST).8-15 The founding National Coordinating Center for NIH StrokeNet (PIs Broderick/Khatri) is housed at the University of Cincinnati. We were recently awarded a large multicenter comparative effectiveness study from PCORI (TESTED; PI Mistry). We were also approved for NIH funding of an innovative Phase 2 trial of novel thrombolytic agent (SISTER; Multiple PIs Khatri/Mistry) and awarded a planning grant for a large endovascular platform (STEP; MPIs Mistry/Khatri), both within NIH StrokeNET. (3) Our career enhancement program. We bring a rich career development environment, as evidenced by our continuously funded NINDS T32 stroke training grant (one of only two in stroke) since 2006, in conjunction with our StrokeNet fellowships, both with academically productive trainees to date. We have also implemented formal and informal education programs to support coordinator career enhancement and job satisfaction. (4) Our departmental and institutional commitment. The Department of Neurology has been augmenting our RCC budget by completing the full salary/benefits of the StrokeNet Fellow, a part-time regulatory coordinator, and RCC project manager. The department has provided salary support to several junior faculty to develop clinical research careers. We have expanded our coordinator team and provided improved space. Building on this foundation, the Ohio Valley RCC seeks a 5-year renewal to continue to advance the following specific aims within the framework of the NIH StrokeNET: Aim 1: Efficiently initiate trials, recruit and retain participants and optimize data quality. We will remain a l
