Network of Excellence in Neuroscience Clinical Trial (NEXT)

描述(由申请者提供)：神经科学临床试验卓越网络(NEXT)是NIH/NINDS建立临床研究网络的一个新的资助机会，以开发和进行严格、科学合理的神经疾病探索性临床试验，这些疾病对成人和儿童都有影响。生物标记物的识别和提炼也是该网络的一个关键目标。NeXT的任务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。计划采用联邦IRB模式和其他形式的集中管理，以促进和加快监管审批。NeXT将为临床现场调查人员和协调员提供支持。德克萨斯大学西南医学中心神经病学和神经治疗学系和儿科神经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。成人神经肌肉科主任吉尔·沃尔夫博士和长期对脊髓性肌萎缩症感兴趣的儿科神经科主任苏珊·扬纳科内博士召集了神经学和相关学科的临床研究人员，并利用社区资源在北得克萨斯州成立了改进神经科学试验登记(INTENT)。此外，德克萨斯大学西南分校设立了临床科学系，由美国国立卫生研究院临床和翻译科学奖(CTSA)支持，为临床试验提供了丰富的支持框架。临床科学系与13个 得克萨斯州北部和中部的机构通过CTSA。因此，与德克萨斯大学西南分校的联系已经到位，以便在机构层面进行合作。此外，德克萨斯大学西南分校的神经科提供者已经形成了来自社区的常见和罕见疾病的强大转诊模式。转诊量很高，这得益于达拉斯-沃斯堡大都市区是美国最大的、只有一所对抗疗法医学院的地区。

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.