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

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8项试验，还有3项正在进行中。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五个州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。初级儿童医院(PCH)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局卫生系统(SLCVAHS)、VISN 19的支撑中心以及运营PCH的山间卫生保健(IHC)。这些系统加在一起为该区域1000万覆盖的生命中的80%以上提供医疗服务。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与NCATS资助的犹他州临床和转化科学研究所建立了密切的合作关系，并从中受益。UR-NEXT领导力和UUH项目提供罕见疾病和基因疗法方面的深厚专业知识，这将使NeuroNEXT财团受益。UUH IRB负责PCH和VAHS，并在全国领导CTSA的CIRB开发，而赞助项目办公室拥有主试验协议方面的经验。作为一家NeuroNEXT网站，UR-NEXT在这一资助期间表现出了高度的参与度和成功。自2017年以来，犹他州参与了6项协议中的5项，在过去四年中有两年是注册人数最多的网站，是NeuroNEXT生命周期内第四高的注册网站，在本资助期内参与者保留率为100%。UR-NEXT领导了NN-108的应用，分析了作为共同主要终点的表皮内神经纤维密度，并回顾了所有研究的神经传导研究。Stacey Clardy是NN-111 Exilish的PDPI，这是一项用于治疗自身免疫性脑炎的inebilizumab住院试验，该试验于2022年开始登记。UR-NEXT包括一项职业提升计划，该计划支持每年一次的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学院研究员。这一计划将受益于与CTSI和UUH副总裁办公室提供的强大的现有职业发展资源的结合。

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.