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: 9293370
• 负责人: Richard B. LIPTON
• 金额: $ 33.24万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE, INC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2018-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9293370
• 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; Eligibility Determination; Ensure; Epidemiology; Epilepsy; Evaluation; Faculty; Foundations; Government; Headache; Health system; Healthcare Systems; Home environment; Hospitals; Huntington Disease; Individual; Industry; Information Systems; Institution; Israel; Laboratories; Leadership; Long Island; Medical center; Medicine; Monitor; National Institute of Neurological Disorders and Stroke; Neurologist; Neurology; Neurosciences; Parkinson Disease; Patient Participation; Patients; Pediatric Neurology; Phase; Population Heterogeneity; Prevention; Process; Protocols documentation; Recruitment Activity; Research Infrastructure; Research Personnel; Resources; Rett Syndrome; Sampling; Site; Specialist; System; Theoretical model; Translations; base; clinical research site; college; disparity reduction; ethnic diversity; experience; follower of religion Jewish; health care delivery; named group; nervous system disorder; north shore long island; novel strategies; patient population; phase II trial; population based; screening; 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）：本提案的总体目标是将爱因斯坦医学院（Einstein）及其附属输送系统作为神经科学临床试验卓越网络（Einstein-NEXT）中的临床研究中心。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150多名成人神经学家和25名儿科神经学家的教师为超过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，包括超过10，000名儿童神经科患者。我们的研究基础设施包括2个CTSA附属的临床研究中心（CRC），并获得优秀的工作人员和CTSA的许多核心，以及北岸的第三个CRC。 每个交付系统在特定疾病领域都有几个神经科学卓越中心，具有特殊人群，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，我们将建立在Einstein-Montefiore CTSA及其临床试验办公室和2个CRC的基础上。目标1：便利快速获取 爱因斯坦及其附属机构的临床试验资源。目标2：优化快速评价和 启动拟议的研究，包括制定有效的方法，以确定、筛选和招募合格患者的各种样本。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，监控我们的研究中心，以确保方案遵守，最大限度地提高数据质量和研究中心效率。我们将通过监督委员会实现这些目标，该委员会将包括Einstein- NEXT的领导团队、临床试验办公室主任和每个研究中心的临床试验负责人。对于每个方案，我们将建立一个研究评估和管理团队，该团队将负责研究的现场和人员配备，促进招募和保留，并监测成功的指标。