Einstein Center for Excellence for Clinical Trials in Neuroscience

描述（由申请人提供）：本提案的总体目标是将爱因斯坦医学院（Einstein）及其附属输送系统建立为神经科学临床试验卓越网络（Einstein - next）的临床站点。我们的附属输送系统包括布朗克斯的Montefiore系统，曼哈顿的Beth Israel医院以及皇后区和长岛的北岸-长岛犹太系统。我们拥有150多名成人神经科医生和25名儿科神经科医生，为超过800万的不同人群提供服务。每年，我们评估超过35,000名神经病学患者，其中包括超过10,000名儿科神经病学患者。我们的研究基础设施包括2个CTSA附属临床研究中心（CRC），拥有优秀的员工和CTSA的许多核心，以及北岸的第三个CRC。每个输送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的人群、临床专业知识和研究基础设施，包括30多名研究协调员。为了利用这些广泛的资源，我们将以Einstein-Montefiore CTSA及其临床试验办公室和2个crc为基础。该提案旨在：目标1：促进快速访问

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.