Einstein Center for Excellence for Clinical Trials in Neuroscience

爱因斯坦神经科学临床试验卓越中心

• 批准号: 8338434
• 负责人: Richard B. LIPTON
• 金额: $ 33.95万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-30 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8338434
• 关键词: Academic Medical Centers; Adherence; Adult; Area; Behavior Therapy; Childhood; Clinical; Clinical Research; Clinical Trials; Cohort Studies; Communities; Community Outreach; Conduct Clinical Trials; Data Quality; Development; Discipline; Disease; Dystonia; Ensure; Epidemiology; Epilepsy; Evaluation; Faculty; Foundations; Government; Headache Syndrome; Health system; Healthcare Systems; Home environment; Hospitals; Huntington Disease; Individual; Industry; Information Systems; Institution; Institutional Review Boards; Israel; Laboratories; Leadership; Long Island; Medical center; Medicine; Metric; Monitor; National Institute of Neurological Disorders and Stroke; Neurologic; Neurologist; Neurology; Neurosciences; Parkinson Disease; Patient Participation; Patients; Pediatric Neurology; Phase; Phase II Clinical Trials; Population Heterogeneity; Prevention; Process; Protocols documentation; Recruitment Activity; Research Infrastructure; Research Personnel; Resources; Rett Syndrome; Sampling; Screening procedure; Site; Specialist; System; Theoretical model; Translations; base; clinical research site; college; experience; follower of religion Jewish; health care delivery; named group; nervous system disorder; north shore long island; novel strategies; patient population; population based; success

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.

描述（由申请人提供）：该提案的总体目标是建立爱因斯坦医学院（Einstein）和我们附属的交付系统，作为神经科学临床试验卓越网络（Einstein-NEXT）中的临床站点。我们的附属输送系统包括布朗克斯的蒙蒂菲奥里系统、曼哈顿的贝斯以色列医院以及皇后区和长岛的北岸-长岛犹太系统。我们的教职人员由 150 多名成人神经科医生和 25 名儿科神经科医生组成，为超过 800 万的多元化人口群体提供服务。每年，我们都会评估超过 35,000 名神经科患者，其中包括超过 10,000 名儿科神经科患者。我们的研究基础设施包括 2 个 CTSA 附属临床研究中心 (CRC)，以及优秀的员工和 CTSA 的许多核心人员以及位于北岸的第三个 CRC。 每个交付系统都在特定疾病领域拥有多个神经科学卓越中心，拥有特殊人群、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，我们将建立在 Einstein-Montefiore CTSA 及其临床试验办公室和 2 个 CRC 的基础上。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、筛选和招募合格患者的不同样本。目标 3：通过应用社区外展和行为干预理论模型来优化患者的参与和保留。目标 4：监控我们的站点，确保遵守协议，通过使用六西格码流程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来实现这些目标，该委员会将包括 Einstein-NEXT 的领导团队、临床试验办公室主任以及每个站点的临床试验领导者。对于每个方案，我们将建立一个研究评估和管理团队，负责研究的地点和人员配置、促进招募和保留并监控成功的指标。