Network of Excellence in Neuroscience Clinical Trial (NEXT)

描述（由申请人提供）：神经科学卓越临床试验网络（NEXT）是NIH/NINDS的一个新的资助机会，旨在建立一个临床研究网络，为影响成人和儿童的神经系统疾病开发和开展严格的、科学合理的探索性临床试验。生物标记物的识别和细化也是该网络的一个关键目标。NEXT的使命是为快速开发和实施协议提供基础设施，以便在多中心框架下更快地测试探索性治疗。计划采用联合IRB模型和其他形式的集中管理来促进和加快监管审批。NEXT将为临床现场调查员和协调员提供支持。德克萨斯大学西南医学中心神经内科和神经治疗科以及儿科神经内科在广泛的神经系统疾病的多中心临床试验方面拥有丰富的经验。Gil Wolfe博士是成人神经肌肉科的主任，Susan Iannaccone博士是儿科神经病学主任，长期对脊髓性肌萎缩症感兴趣，他们召集了神经病学和相关学科的临床研究人员，并利用社区资源在北德克萨斯建立了改善神经科学试验登记（INTENT）。此外，UT西南已经建立了一个临床科学系，由NIH临床和转化科学奖（CTSA）支持，为临床试验提供了丰富的支持框架。临床科学系有13个合作伙伴

DESCRIPTION (provided by applicant): The Network for Excellence in Neuroscience Clinical Trials (NEXT) is a new funding opportunity of the NIH/NINDS to establish a clinical research network to develop and conduct rigorous, scientifically-sound exploratory clinical trials for neurologic diseases that affect both adults and children. Biomarker identification and refinement is also a key goal of the network. NEXT's mission is to provide an infrastructure for the rapid development and implementation of protocols so that exploratory treatments can more quickly be tested in a multicenter framework. A federated IRB model and other forms of centralized administration are planned to facilitate and expedite regulatory approvals. NEXT will provide support for clinical site investigators and coordinators. The Department of Neurology and Neurotherapeutics and the Division of Pediatric Neurology at UT Southwestern Medical Center have extensive experience in multicenter clinical trials across a broad spectrum of neurological disorders. Dr. Gil Wolfe, who directs the adult neuromuscular division, and Dr. Susan Iannaccone, Chief of Pediatric Neurology with a longstanding interest in spinal muscular atrophy, have assembled clinical investigators in neurology and related disciplines and leveraged community resources to form the Improving Neuroscience Trials Enrollment in North Texas (INTENT). In addition, UT Southwestern has established a Department of Clinical Sciences supported by an NIH Clinical and Translational Science Award (CTSA) that provides a rich framework of support for clinical trials. The Department of Clinical Sciences partners with 13 institutions in North and Central Texas through the CTSA. As a result, links to UT Southwestern are already in place for cooperative efforts at the institutional level. In addition, neurology providers at UT Southwestern have developed strong referral patterns from the community for both common and rare diseases. Referral volumes are high and benefit from the fact that the Dallas-Fort Worth metropolitan area is the largest in the United States with a single allopathic medical school.