Heartland Unit for Neuroscience Trials

描述（由申请人提供）：堪萨斯大学（KU）在神经学临床和转化研究方面有着丰富的历史和投资组合，有150多个正在进行的神经科学相关临床试验。近年来，堪萨斯城的临床和转化研究加速发展，堪萨斯大学的推进医学创新研究所已成为全国药物开发的领导者。堪萨斯大学将利用这一势头，成立心脏地带神经科学试验中心（HUNT），提供基础设施、集中资源、接触患者和协调本地区的神经科学研究人员，从而提高他们对NEXT试验的响应能力和开展这些试验的效率。HUNT将整合并利用现有的机构资源，形成两个专门致力于有效满足研究要求的特定核心：监管核心（RC）和外展核心（OC）。研究中心将提供全方位的规管和合约支援服务，而法团则会扩大潜在研究参与者的人数，并与研究人员合作，以超越招聘目标。在过去的二十年里，堪萨斯大学研究所为研究人员提供了全面的监管和合同支持。最近，堪萨斯大学开发了一个研究参与者注册计划，部署在门诊诊所，并由一个新的生物信息学计划提供支持。这些现有资源使我们能够很好地将HUNT发展为一个综合和有凝聚力的单位，以支持该地区的专业神经科学研究人员。具体来说，HUNT的目标是：1)通过提供一个协调的区域专家研究小组，为全面的监管支持提供RC，为扩大潜在研究参与者提供OC，从而提高神经系统疾病特异性临床试验的效率和质量；2)通过在整个地区和堪萨斯州培训新的研究人员，扩大神经系统疾病特异性临床试验的范围；3)增强NEXT联盟在转化药物开发方面的独特能力。

DESCRIPTION (provided by applicant): The University of Kansas (KU) has a rich history and portfolio of neurological clinical and translational research, with over 150 active neuroscience-related clinical trials. Clinical and translational research in Kansas City has accelerated in recet years, and KU's Institute for Advancing Medical Innovations has become a national leader in drug development. KU will capitalize on this momentum and form the Heartland Unit for Neuroscience Trials (HUNT) to provide infrastructure, centralized resources, access to patients, and coordination of our region's neuroscience investigators, thereby increasing their responsiveness to NEXT trials and efficiency in conducting those trials. The HUNT will integrate with and draw on existing institutional resources to form two specific cores dedicated to efficiently meet study requirements: a Regulatory Core (RC) and an Outreach Core (OC). The RC will provide full-service regulatory and contractual support, while the OC will expand the pool of potential research participants and work with investigators to exceed recruitment goals. For the last two decades, KU's Research Institute has supported investigators with comprehensive regulatory and contractual support. More recently, KU developed a Research-Participant-Registration Program deployed across outpatient clinics and supported by a new Bioinformatics program. These existing resources position us well to develop the HUNT as an integrated and cohesive unit for supporting the region's specialist neuroscience investigators. Specifically, the HUNT aims to 1) increase the efficiency and quality of neurological-disease-specific clinical trials by providing a coordinated regional team of specialist investigators with an RC for comprehensive regulatory support and an OC for expanding the pool of potential study participants; 2) extend the reach of neurological-disease-specific clinical trials by training new investigators across the region and the state of Kansas; and 3) enhance the NEXT consortium with unique capabilities for translational drug development. PUBLIC HEALTH RELEVANCE: The Heartland Unit of Neuroscience Trials will participate in clinical trials sponsored by the Network of Excellence in Neuroscience Clinical Trials with the goal of developing new therapies for neurological diseases in children and adults.