Network of Excellence in Neuroscience Clinical Trial (NEXT)

神经科学临床试验卓越网络 (NEXT)

• 批准号: 8339419
• 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 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8339419
• 关键词: Academic Medical Centers; Adult; Affect; African American; Area; Award; Biological Markers; Child; Clinical; Clinical Investigator; Clinical Research; Clinical Sciences; Clinical Trials; Clinical Trials Network; Clinical and Translational Science Awards; Commit; 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; clinical research site; experience; improved; interest; medical schools; metropolitan; nervous system disorder; neuromuscular; novel; 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.

描述（由申请人提供）：神经科学临床试验的卓越网络（下一个）是NIH/NINDS的新资金机会，旨在建立一个临床研究网络，以开发和进行严格的，科学的探索性探索性临床试验，以针对影响成人和儿童的神经系统疾病。生物标志物识别和完善也是网络的关键目标。 Next的使命是为快速开发和实施协议提供基础架构，以便在多中心框架中更快地测试探索性处理。计划促进和加快监管部门的批准，并计划采用联合IRB模型和其他形式的集中管理。接下来将为临床现场调查人员和协调员提供支持。 UT西南医学中心的神经学和神经疗法系以及儿科神经病学部在各种神经系统疾病的多中心临床试验方面拥有丰富的经验。导演成人神经肌肉部门的吉尔·沃尔夫（Gil Wolfe）博士和儿科神经病学负责人苏珊·伊安纳克科内（Susan Iannaccone）博士对脊柱肌肉萎缩的兴趣长期感兴趣，他们在神经病学和相关的学科和杠杆作用方面都组装了临床研究者，并杠杆化的社区资源是在北德克萨斯（North Texas）（Intects Intents in of North Texas（Intect）招募的临床资源）。此外，UT Southwestern已建立了由NIH临床和转化科学奖（CTSA）支持的临床科学系，该奖项为临床试验提供了丰富的支持框架。临床科学系与13 北部和德克萨斯州中部的机构通过CTSA。结果，在机构一级的合作努力已经建立了与UT西南部的链接。此外，UT Southwestern的神经病学提供者为常见和稀有疾病开发了社区的强烈推荐模式。转介量很高，受益于达拉斯 - 沃思堡的大都市地区是美国最大的，拥有一所同种疗法医学院。