Einstein Center for Excellence for Clinical Trials in Neuroscience

描述(由申请人提供)：这项建议的总体目标是建立爱因斯坦医学院(爱因斯坦)和我们的附属交付系统，作为神经科学临床试验卓越网络(爱因斯坦-NEXT)的一个临床网站。我们的附属系统包括布朗克斯的Montefiore系统、曼哈顿的贝丝以色列医院以及皇后区和长岛的北岸-长岛犹太人系统。我们由150多名成人神经学家和25名儿科神经学家组成的教职员工为超过800万的多样化人口提供服务。每年，我们评估超过35,000名神经科患者，其中包括10,000多名儿科神经科患者。我们的研究基础设施包括两个CTSA附属的临床研究中心(CRC)，以及CTSA的优秀员工和许多核心人员，以及位于北岸的第三个CRC。每个交付系统都有几个神经科学卓越中心，在特定的疾病领域拥有特殊人口、临床专业知识和研究基础设施，其中包括30多名研究协调员。为了利用这些广泛的资源，我们将在爱因斯坦-蒙特菲奥里CTSA及其临床试验办公室和2个CRC的基础上再接再厉。该提案旨在：目标1：促进快速访问 爱因斯坦及其附属机构的临床试验资源。目标2：优化快速评估和 启动拟议的研究，包括开发有效的方法来识别、筛选和招募不同的合格患者样本。目的3：通过社区外展和行为干预理论模型的应用，优化患者的参与和保留。目标4：通过使用六西格玛流程，监控我们的站点以确保遵守协议，最大限度地提高数据质量和站点效率。我们将通过一个监督委员会实现这些目标，该委员会将包括爱因斯坦-NEXT的领导团队、临床试验办公室主任和每个地点的临床试验负责人。对于每个方案，我们将建立一个研究评估和管理小组，负责研究的地点和工作人员，促进招聘和保留，并监测成功的衡量标准。

DESCRIPTION (provided by applicant): The overall aim of this proposal is to establish the Einstein College of Medicine (Einstein) and our affiliated delivery systems as a Clinical Site in the Network for Excellence in Neuroscience Clinical Trials (the Einstein-NEXT). Our affiliated delivery systems include the Montefiore System in the Bronx, the Beth Israel Hospital in Manhattan and the North Shore-Long Island Jewish System in Queens and Long Island. Our faculty of over 150 adult neurologists and 25 pediatric neurologists serve a remarkably diverse population base of over 8 million. Each year, we assess over 35,000 individual neurology patients, including more than 10,000 pediatric neurology patients. Our research infrastructure includes 2 CTSA affiliated Clinical Research Centers (CRCs) and access to excellent staff and many Cores of the CTSA and a third CRC at North Shore. Each delivery system has several Neuroscience Centers of Excellence in particular disease areas with special populations, clinical expertise and research infrastructure, including more than 30 study coordinators. To leverage these extensive resources, we will build on the foundation of the Einstein-Montefiore CTSA with its Office of Clinical Trials and its 2 CRCs. This proposal aims to: Aim 1: Facilitate rapid access to clinical trial resources at Einstein and affiliates. Aim 2: To optimize the rapid evaluation and launch of proposed studies, including development of efficient approaches for identifying, screening and recruiting diverse samples of eligible patients. Aim 3: To optimize patient participation and retention through the application of community outreach and a behavioral intervention theoretical model. Aim 4: To monitor our sites to ensure protocol adherence, maximize data quality and site efficiency through the use of Six Sigma processes. We will achieve these aims through an Oversight Committee which will include the leadership team for the Einstein- NEXT, the Director of the Office of Clinical Trials and clinical trial leaders from each of the sites. For each protocol, we will develop a Study Assessment and Management Team, which will site and staff the study, facilitate recruiting and retention and monitor metrics f success.