The Utah Regional Network for Excellence in Neuroscience Clinical Trials

多中心临床试验面临许多挑战，包括招募、缺乏临床试验专业知识，以及IRB批准和签约效率低下。神经科学临床试验卓越网络(NeuroNEXT)通过组织25个研究站点以及中央数据和临床协调中心解决了这些问题，每个中心都拥有临床试验设计和性能方面的重要专业知识，并可以接触到广泛的内容专家。NeuroNEXT有一个中央IRB(CIRB)和主试验协议(MTA)，可以提高启动效率。NeuroNEXT已经完成了3项试验，第4项完成了开放标签延期；另外3项正在登记，1项将于11/17开始登记，1项刚刚获得资金。这4名学生中的每一名都提前或提前完成了注册。每个都拥有快速启动和出色的数据准确性/质量。神经科学临床试验卓越网络(UR-NEXT)中的犹他州地区站点是为5个州的山间西部提供服务的NeuroNEXT临床研究站点。UR-NEXT中心设在犹他大学健康学院(UUU)。UUH拥有该地区唯一的综合神经科学中心。初级儿童医疗中心(PCMC)是唯一的儿童医院，是合作伙伴。UR-NEXT还包括盐湖城退伍军人管理医疗中心(SLCVAMC)、VISN 19的锚定中心和施林内斯儿童医院。UR-NEXT基本上可以接触到该地区的所有患者(覆盖了800万人的生命)。山间保健(IHC)是最大的保健系统，与UUH合作运营PCMC，是关键的研究合作伙伴。UR-NEXT受益于已建立的对临床试验感兴趣的社区神经学家推荐网络，即西部山间神经学组织(WINO)。神经科在每个主要分科都有分部，在多中心试验的管理和执行方面拥有丰富的专业知识。UR-NEXT受益于与NCATS资助的临床和转化科学与试验创新中心以及众多其他资源的密切合作关系。UUU IRB负责PCMC和SLCVAMC，并愿意继续参与NeuroNEXT CIRB。赞助项目办公室有使用主试验协议的历史，并已同意继续对NeuroNEXT使用主试验协议。在第一个资助期，UR-NEXT高度参与并取得了成功，参与了7/8的选址研究(并自愿参加了nN109)。UR-Next一直是注册人数最多的网站之一，也是启动时间最快的网站之一。史密斯博士，UR-NEXT PI，也是NN108的PI，NN108是治疗隐源性感觉神经病(TopCSPN研究)的托吡酯，也是NeuroNEXT执行委员会的成员。UR-NEXT现在将包括一个新的职业提升计划，包括支持每年一次的UR-NEXT奖学金，该奖学金将授予对临床试验感兴趣的有前途的早期教师研究员。该计划将受益于通过CCTS、TIC和副总统办公室提供的强大的现有职业发展资源。

Multicenter clinical trials face numerous challenges including recruitment, lack of clinical trial expertise, and inefficiencies in IRB approval and contracting. The Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) has addressed these by organizing 25 research sites and central Data and Clinical Coordinating centers, each with significant expertise in clinical trial design and performance and access to a broad range of content experts. NeuroNEXT has a Central IRB (cIRB) and master trial agreement (MTA) that increased startup efficiency. NeuroNEXT has completed 3 trials, with a 4th finishing an open label extension; 3 others are enrolling, 1 will begin enrolling 11/17, and 1 was just funded. Each of the 4 having finished enrollment did so on or ahead of time. Each shares rapid startup and excellent data accuracy/qualty. The Utah Regional site in the Network for Excellence in Neuroscience Clinical Trials (UR-NEXT) is the NeuroNEXT clinical research site serving the 5 state Intermountain West. UR-NEXT is centered at University Utah Health (UUH). UUH has the only integrated neuroscience center in the region. Primary Children’s Medical Center (PCMC) is the only children’s hospital and serves as partner. UR-NEXT also includes the Salt Lake City Veteran's Administration Medical Center (SLCVAMC), the anchoring center for VISN 19, and Shriners Children’s Hospital. UR-NEXT has access to essentially all patients in the region (8 million covered lives). Intermountain Health Care (IHC) is the largest health care system, operates PCMC in cooperation with UUH, and is a key research partner. UR- NEXT benefits from an established network of referring community neurologists with interest in clinical trials, the Western Intermountain Neurological Organization (WINO). The Neurology Department has Divisions in each major subspecialty with substantial expertise in the management and performance of multicenter trials. UR-NEXT benefits from a close collaborative relationship with the NCATS funded Center for Clinical and Translational Science and Trial Innovation Center as well as numerous other resources. The UUH IRB is responsible for PCMC and the SLCVAMC and is willing to continue to participate in the NeuroNEXT cIRB. The Office of Sponsored Projects has a history of using master trial agreements, and has agreed to continue to do so for NeuroNEXT. During the first funding period UR-NEXT was highly engaged and successful, participating in 7/8 studies for which site selection has taken place (and has volunteered for nN109). UR-NEXT has been one of the highest enrolling sites with one of the fastest startup times. Dr. Smith, UR-NEXT PI, is also PI of NN108, the Topiramate for Cryptogenic Sensory Neuropathy (the TopCSPN Study), and a member of the NeuroNEXT Executive Committee. UR-NEXT will now include a new Career Enhancement Plan including support for a yearly UR-NEXT Fellowship which will be awarded to a promising early career faculty investigator interested in clinical trials. This program will benefit from alignment with robust existing career development resources available through the CCTS, TIC and Vice President’s office.