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.
As new approaches to the treatment of neurological disease emerge rapid translation requires efficient Phase II trials. Herein, we propose to leverage the Einstein CTSA with its CRCs, our Neuroscience Centers of Excellence, our outstanding faculty in adult and child neurology and adjacent disciplines, our experience in clinical trials as well as our enormous and diverse patient populations to establish the Einstein-NEXT.
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