The Utah Regional Network for Excellence in Neuroscience Clinical Trials

多中心临床试验面临着许多挑战，包括招募，缺乏临床试验专业知识，以及IRB批准和合同的效率低下。神经科学临床试验卓越网络（NeuroNEXT）通过组织25个研究中心和中央数据和临床协调中心来解决这些问题，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，并可以获得广泛的内容专家。NeuroNEXT有一个中央IRB（cIRB）和主试验协议（MTA），提高了启动效率。NeuroNEXT已经完成了3项试验，第4项完成了开放标签扩展;另外3项正在招募，1项将于11/17开始招募，1项刚刚获得资助。4名完成入组的患者均提前或提前完成入组。每个共享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）中的犹他州区域研究中心是服务于5个州Intermountain West的NeuroNEXT临床研究中心。UR-NEXT以犹他州健康大学（UUH）为中心。UUH拥有该地区唯一的综合神经科学中心。小学儿童医疗中心（PCMC）是唯一的儿童医院，并作为合作伙伴。UR-NEXT还包括湖城退伍军人管理局医疗中心（SLCVAMC）、VISN 19的锚定中心和施里纳儿童医院。UR-NEXT基本上可以接触到该地区的所有患者（覆盖800万人）。Intermountain Health Care（IHC）是最大的医疗保健系统，与UUH合作运营PCMC，并且是关键的研究合作伙伴。UR- NEXT受益于对临床试验感兴趣的社区神经学家的既定网络，即西部山间神经组织（WINO）。神经内科在每个主要的子专业都设有科室，在多中心试验的管理和实施方面具有丰富的专业知识。UR-NEXT受益于与NCATS资助的临床和转化科学中心和试验创新中心以及许多其他资源的密切合作关系。UUH 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，并已同意继续为NeuroNEXT这样做。在第一个供资期内，UR-NEXT高度参与并取得成功，参与了7/8项研究，并已进行了研究中心选择（并自愿参加了nN 109）。UR-NEXT是注册人数最多的网站之一，启动时间最快。史密斯博士，UR-NEXT PI，也是NN 108的PI，托吡酯治疗隐源性感觉神经病（TopCSPN研究），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，包括支持每年的UR-NEXT奖学金，该奖学金将颁发给对临床试验感兴趣的有前途的早期职业研究人员。该计划将受益于通过CCTS，TIC和副总裁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.