Heartland Unit for Neuroscience Trials

描述(由申请人提供)：堪萨斯大学(KU)拥有丰富的神经学临床和翻译研究历史和组合，拥有150多项与神经科学相关的活跃临床试验。堪萨斯城的临床和转化研究在最近几年得到了加速，KU的先进医学创新研究所已经成为全国药物开发的领先者。Ku将利用这一势头，成立神经科学试验心脏地带单位(Hunt)，为本地区的神经科学研究人员提供基础设施、集中资源、接触患者和协调，从而提高他们对下一步试验的响应能力和进行这些试验的效率。猎人计划将整合和利用现有的机构资源，形成两个专门用于有效满足研究要求的具体核心：监管核心(RC)和外展核心(OC)。RC将提供全方位的监管和合同支持，而OC将扩大潜在研究参与者的人才库，并与调查人员合作，以超过招聘目标。在过去的二十年里，KU的研究所为调查人员提供了全面的监管和合同支持。最近，KU开发了一个研究-参与者-注册计划，部署在门诊诊所，并得到一个新的生物信息学计划的支持。这些现有资源使我们能够很好地将Hunt发展为一个支持该地区专门神经科学研究人员的综合和有凝聚力的单位。具体地说，Hunt的目标是：1)通过提供一个协调的区域专家调查团队，提供全面监管支持的RC和扩大潜在研究参与者库的OC，从而提高神经疾病特定临床试验的效率和质量；2)通过培训整个地区和堪萨斯州的新研究人员，扩大神经疾病特定临床试验的覆盖范围；以及3)加强下一个具有翻译药物开发独特能力的财团。 公共卫生相关性：神经科学试验中心将参加由神经科学临床试验卓越网络赞助的临床试验，目标是开发儿童和成人神经系统疾病的新疗法。

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.