Network of Excellence in Neuroscience Clinical Trial (NEXT)

神经科学临床试验卓越网络 (NEXT)

• 批准号: 9085400
• 负责人: Mark Paul Goldberg
• 金额: $ 31.8万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 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 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9085400
• 关键词: Academic Medical Centers; Adult; Affect; African American; Area; Award; Child; Clinical; Clinical Investigator; Clinical Research; Clinical Sciences; Clinical Trials; Clinical Trials Network; Clinical and Translational Science Awards; Communication; Communities; Community Healthcare; Country; Data Coordinating Center; Development; Discipline; Disease; Enrollment; Epilepsy; Fostering; Foundations; Funding Opportunities; Future; Goals; Health Personnel; Healthcare; Hispanic Americans; Hospitals; Institution; Institutional Review Boards; Intervention; Intervention Studies; Investigational Therapies; Leadership; Link; Medical center; Memory Disorders; Mission; Modeling; Movement Disorders; Multiple Sclerosis; National Institute of Neurological Disorders and Stroke; Neurologic; Neurology; Neuromuscular Diseases; Neurosciences; Patients; Pattern; Pediatric Neurology; Population; Population Heterogeneity; Protocols documentation; Provider; Rare Diseases; Recruitment Activity; Research Infrastructure; Research Personnel; Resources; Scholarship; Site; Spinal Muscular Atrophy; Stroke; Testing; Texas; Training; Translating; Translational Research; United States; United States National Institutes of Health; Universities; Vision; biomarker identification; clinical research site; experience; improved; interest; medical schools; metropolitan; nervous system disorder; neuromuscular; novel; novel therapeutics; programs; sound; success

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.

神经科学临床试验卓越网络（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进行严格的，科学合理的探索性临床试验。生物标志物识别和细化也是网络的一个关键目标。NEXT的使命是为快速开发和实施方案提供基础设施，以便在多中心框架中更快地测试探索性治疗。计划采用联合IRB模式和其他形式的集中管理，以促进和加快监管审批。NEXT将为临床研究中心研究者和协调员提供支持。UT西南医学中心的神经病学和神经治疗学系以及儿科神经病学系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。指导成人神经肌肉部门的Gil Wolfe博士和长期对脊髓性肌萎缩症感兴趣的儿科神经科主任Susan Iannaccone博士召集了神经科和相关学科的临床研究人员，并利用社区资源形成了德克萨斯州北部的改善神经科学试验招募（INTENT）。此外，UT Southwestern还建立了由NIH临床和转化科学奖（CTSA）支持的临床科学系，为临床试验提供了丰富的支持框架。临床科学部与13个 德克萨斯州北部和中部的机构通过CTSA。因此，与UT西南的联系已经到位，在机构层面的合作努力。此外，UT西南的神经病学提供者已经从社区中为常见和罕见疾病开发了强大的转诊模式。转诊量很高，并受益于达拉斯-沃斯堡大都市区是美国最大的单一对抗疗法医学院。