The Utah Regional Network for Excellence in Neuroscience Clinical Trials (UR-NEXT)

多中心临床试验面临着许多挑战，包括招聘、缺乏临床试验专业知识以及IRB审批和合同效率低下。神经科学临床试验卓越网络（NeuroNEXT）通过组织25个研究站点和中央数据和临床协调中心来解决这些问题，每个中心都具有临床试验设计和性能方面的重要专业知识，并可以访问广泛的内容专家。NeuroNEXT具有中央IRB （cIRB）和主试验协议（MTA），可提高启动效率。NeuroNEXT已经完成了8项试验，还有3项处于活跃状态。神经科学临床试验卓越网络（UR-NEXT）的犹他州区域站点是为西部五州提供服务的NeuroNEXT临床研究站点。UR-NEXT以犹他大学健康中心（UUH）为中心。UUH拥有该地区唯一的综合性神经科学中心。初级儿童医院（PCH）是唯一的儿童医院，并作为合作伙伴。UR-NEXT还包括盐湖城退伍军人管理卫生系统（SLCVAHS）， VISN 19的锚定中心，以及运营PCH的山间医疗保健（IHC）。这些系统共同为该地区覆盖的1000万人中的80%以上提供医疗服务。UR-NEXT受益于对临床试验感兴趣的转诊社区神经学家网络，即西部山间神经学组织（WINO）。神经内科在每个主要亚专科都设有分部，在多中心试验的管理和表现方面具有丰富的专业知识。UR-NEXT与NCATS资助的犹他州临床和转化科学研究所共享领导地位，并受益于密切的合作关系。UR-NEXT的领导和UUH的项目在罕见疾病和基因治疗方面提供了深厚的专业知识，这将使NeuroNEXT联盟受益。UUH IRB负责PCH和VAHS，并在全国范围内领导CTSA的cIRB开发，而赞助项目办公室则具有主试验协议的经验。UR-NEXT作为一个NeuroNEXT网站，在此融资期间一直高度参与并取得成功。自2017年以来，犹他州参与了6个方案中的5个，在过去四年中有两年是最大的注册地点，在NeuroNEXT生命周期中是第四大注册地点，在当前资助期间参与者的保留率为100%。UR- NEXT领导给药NN-108，分析表皮内神经纤维密度作为共同主要终点，并回顾所有神经传导研究。Stacey Clardy是NN-111 ExTINGUISH的PDPI，这是一项用于治疗自身免疫性脑炎的奈比利单抗住院试验，于2022年开始招募。UR-NEXT包括一个职业提升计划，该计划支持每年的UR-NEXT奖学金，该奖学金授予对临床试验感兴趣的有前途的早期职业神经科学教师研究者。该项目将受益于CTSI和UUH副校长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 increases startup efficiency. NeuroNEXT has completed 8 trials, and three more are active. The Utah Regional site in the Network for Excellence in Neuroscience Clinical Trials (UR-NEXT) is the NeuroNEXT clinical research site serving the five 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 Hospital (PCH) is the only children's hospital and serves as partner. UR-NEXT also includes the Salt Lake City Veteran's Administration Health System (SLCVAHS), the anchoring center for VISN 19, and Intermountain Health Care (IHC), which operates PCH. Together these systems provide medical services to more than 80% of the 10 million covered lives in the region. 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 shares leadership with, and benefits from a close collaborative relationship with the NCATS funded Utah Clinical and Translational Sciences Institute. UR-NEXT leadership and UUH programs provide deep expertise in rare diseases and genetic therapies that will benefit the NeuroNEXT consortium. The UUH IRB is responsible for PCH and VAHS, and leads cIRB development for the CTSA nationally, while the Office of Sponsored Projects has experience with master trial agreements. UR-NEXT has been highly engaged and successful as a NeuroNEXT site during this funding period. Utah participated in 5 of 6 protocols since 2017 and was the top enrollment site in two of the past four years, the fourth highest enrolling site over the NeuroNEXT lifespan, with 100% retention of participants during the current funding period. UR- NEXT led administration of NN-108, analyzed intraepidermal nerve fiber density as the co-primary endpoint and reviewed all study nerve conduction studies. Stacey Clardy is PDPI for NN-111 ExTINGUISH, an inpatient trial of inebilizumab for treatment of autoimmune encephalitis, which began enrolling in 2022. UR-NEXT includes a Career Enhancement Plan that supports a yearly UR-NEXT Fellowship which is awarded to a promising early career neurosciences faculty investigator interested in clinical trials. This program will benefit from alignment with robust existing career development resources available through the CTSI and UUH Vice President's office.