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

犹他州神经科学临床试验卓越区域网络 (UR-NEXT)

• 批准号: 10744970
• 负责人: Josh Leitch Bonkowsky
• 金额: $ 42.31万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-01 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10744970
• 关键词: Address; Adopted; Adult; Affect; Agreement; Autoimmune encephalitis; Award; COVID-19; Childhood; Cities; Clinical; Clinical Investigator; Clinical Sciences; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Collaborations; Communities; Complex; Contracts; Data; Development; Disease; Enrollment; Environment; Ethnic Origin; Face; Faculty; Feedback; Fellowship; Funding; Genome; Grant; Health; Health system; Healthcare; Home; Hospital Administration; Human Resources; Infrastructure; Inpatients; Institution; Institutional Review Boards; Leadership; Longevity; Master of Science; Measures; Medical; Mentorship; Multi-Institutional Clinical Trial; Multicenter Trials; N-Methyl-D-Aspartate Receptors; National Center for Advancing Translational Sciences; National Institute of Neurological Disorders and Stroke; Nerve Fibers; Neurobiology; Neurologic; Neurologist; Neurology; Neuropsychology; Neurosciences; Neurosciences Research; Only Child; Participant; Patient Recruitments; Patients; Pediatric Hospitals; Pediatric Neurology; Performance; Play; Population; Population Database; Population Heterogeneity; Positioning Attribute; Protocols documentation; Race; Randomized; Randomized, Controlled Trials; Rare Diseases; Research; Research Personnel; Resource Development; Resources; Role; Rural; Rural Population; Scholars Program; Secure; Services; Site; Sodium Chloride; Structure; System; Techniques; Therapeutic; Therapy trial; Training; Training Programs; Translational Research; Universities; Utah; Veterans Health Administration; Writing; biomarker development; biomarker validation; career; career development; clinical investigation; clinical research site; cohort; community engagement; cost effective; density; design; disease phenotype; effective therapy; experience; frontier; gene therapy; improved; innovation; interest; leukodystrophy; member; nerve conduction study; nervous system disorder; neurosurgery; novel; participant retention; patient population; peer; primary endpoint; programs; protocol development; recruit; retention rate; rurality; skill acquisition; skills; success; translational neuroscience; trial design

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.

多中心临床试验面临着众多挑战，包括招募、缺乏临床试验专业知识以及 IRB 审批和签约效率低下。神经科学临床试验卓越网络 (NeuroNEXT) 通过组织 25 个研究中心以及中央数据和临床协调中心来解决这些问题，每个中心都在临床试验设计和执行方面拥有丰富的专业知识，并且可以接触到广泛的内容专家。 NeuroNEXT 拥有中央 IRB (cIRB) 和主试验协议 (MTA)，可提高启动效率。 NeuroNEXT 已完成 8 项试验，还有 3 项试验正在进行中。神经科学临床试验卓越网络 (UR-NEXT) 中的犹他州地区站点是服务于 Intermountain West 五个州的 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神经科学中心。小学儿童医院（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健康系统 (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 1000 万人口中的 80% 以上提供医疗服务。 UR-NEXT 受益于对临床试验感兴趣的社区神经科医生的既定网络，即西部山间神经组织 (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共享领导地位，并从密切的合作关系中受益。 UR-NEXT 领导层和 UUH 项目提供了罕见疾病和基因疗法方面的深厚专业知识，这将使 NeuroNEXT 联盟受益。 UUH IRB 负责 PCH 和 VAHS，并领导全国 CTSA 的 cIRB 开发，而赞助项目办公室则拥有主试验协议方面的经验。在此资助期间，UR-NEXT 作为 NeuroNEXT 网站获得了高度参与并取得了成功。自 2017 年以来，犹他州参与了 6 个协议中的 5 个，并且在过去四年中有两年是最多的注册地点，是 NeuroNEXT 生命周期中第四高的注册地点，在当前资助期间参与者的保留率为 100%。 UR-NEXT 主导 NN-108 的给药，分析表皮内神经纤维密度作为共同主要终点，并审查所有研究神经传导研究。 Stacey Clardy 是 NN-111 ExTINGUISH 的 PDPI，这是一项用 inebilizumab 治疗自身免疫性脑炎的住院试验，于 2022 年开始入组。UR-NEXT 包括一项职业提升计划，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员研究员。该计划将受益于与 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。

项目成果

Optical coherence tomography outcomes from SPRINT-MS, a multicenter, randomized, double-blind trial of ibudilast in progressive multiple sclerosis.

• DOI: 10.1177/1352458520964409
• 发表时间: 2021-08
• 期刊: Multiple sclerosis (Houndmills, Basingstoke, England)
• 作者: Bermel RA;Fedler JK;Kaiser P;Novalis C;Schneebaum J;Klingner EA;Williams D;Yankey JW;Ecklund DJ;Chase M;Naismith RT;Klawiter EC;Goodman AD;Coffey CS;Fox RJ
• 通讯作者: Fox RJ

Extracranial carotid artery atherosclerotic plaque and APOE polymorphisms: a systematic review and meta-analysis.

• DOI: 10.3389/fcvm.2023.1155916
• 发表时间: 2023
• 期刊: FRONTIERS IN CARDIOVASCULAR MEDICINE
• 影响因子: 3.6
• 作者: Culleton, Sinead;Niu, Mary;Alexander, Matthew;McNally, J. Scott;Yuan, Chun;Parker, Dennis;Baradaran, Hediyeh
• 通讯作者: Baradaran, Hediyeh