The Utah Regional Network for Excellence in Neuroscience Clinical Trials

犹他州神经科学临床试验卓越区域网络

• 批准号: 10593643
• 负责人: John Robinson Singleton
• 金额: $ 30.5万
• 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 2023-07-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10593643
• 关键词: Academia; Address; Adult; Affect; Agreement; Arizona; Award; Basic Science; Center for Translational Science Activities; Child; Childhood; Cities; Clinical; Clinical Research; Clinical Sciences; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Collaborations; Colorado; Communities; Complex; Contracts; Data; Development; Disease; Education; Enrollment; Ensure; Environment; Face; Faculty; Fellowship; Foundations; Funding; Grant; Health; Health system; Healthcare; Healthcare Systems; Human Resources; Human Subject Research; Infrastructure; Institutional Review Boards; International; Knowledge; Leadership; Master' s Degree; Medical center; Mentors; Mentorship; Methods; Mind; Modeling; Montana; Multi-Institutional Clinical Trial; Multicenter Trials; National Center for Advancing Translational Sciences; National Institute of Neurological Disorders and Stroke; Natural History; Nervous system structure; Neurobiology; Neurologic; Neurologist; Neurology; Neuropsychology; Neurosciences; Neurosciences Research; Nevada; Only Child; Patient Recruitments; Patients; Pediatric Hospitals; Pediatric Neurology; Performance; Pharmacologic Substance; Population; Population Heterogeneity; Positioning Attribute; Recording of previous events; Research; Research Personnel; Resource Development; Resources; Site; Sodium Chloride; Spinal Muscular Atrophy; Stroke; Structure; Time; Training Programs; Translational Research; Translational trial; Translations; United States Department of Veterans Affairs; United States National Institutes of Health; Universities; Utah; Vision; Writing; biomarker development; biomarker validation; biopharmaceutical industry; career; career development; clinical center; clinical implementation; clinical investigation; clinical research site; community engagement; cost effective; design; early-career faculty; effective therapy; experience; health care delivery; improved; innovation; interest; medical schools; member; nervous system disorder; neurosurgery; novel; open label; patient population; pediatric patients; peer; programs; protocol development; recruit; sensory neuropathy; skills; success; supportive environment; therapeutic target; topiramate; trial design; volunteer

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.

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。每个公司都在临床试验设计和绩效方面拥有丰富的专业知识，并且拥有广泛的内容专家，并拥有中央 IRB (cIRB) 和主试验协议 (MTA)，从而提高了 NeuroNEXT 的启动效率。 3 项试验，第 4 项完成开放标签延期；另外 3 项正在招募，1 项将于 11/17 开始招募，1 项刚刚完成招募，每项都已完成或提前启动。卓越神经科学临床试验网络 (UR-NEXT) 中的犹他州地区站点是服务于 Intermountain West 5 个州的 NeuroNEXT 临床研究站点。犹他大学健康中心 (UUH) 拥有该地区唯一的综合神经科学中心 (PCMC)，也是唯一的儿童医院，并且是 UR-NEXT 的合作伙伴。 ) )，VISN 19 和 UR-NEXT 的锚定中心几乎可以覆盖该地区的所有患者（涵盖 800 万人的山间医疗保健）。 (IHC) 是最大的医疗保健系统，与 UUH 合作运营 PCMC，并且是 UR-NEXT 的主要研究合作伙伴，受益于对临床试验感兴趣的社区转诊神经科医生网络，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多个部门，在多中心试验的管理和执行方面拥有丰富的专业知识，这得益于与 NCATS 资助的临床和转化科学与试验创新中心的密切合作关系。 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，并同意继续参与。在第一个资助期间，UR-NEXT 高度参与并取得了成功，参与了已进行选址的 7/8 研究（并自愿参与 nN109）。 UR-NEXT 是注册人数最多、启动时间最快的网站之一。Smith 博士是 UR-NEXT PI，也是治疗隐源性感觉神经病的托吡酯 NN108 的 PI（TopCSPN 研究）。 NeuroNEXT 执行委员会现在将包括一项新的职业提升计划，其中包括对每年 UR-NEXT 奖学金的支持，该奖学金将颁发给对以下领域感兴趣的有前途的早期职业教员研究员：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。

项目成果

Diagnosis of neuropathy: comment on "tests and expenditures in the initial evaluation of peripheral neuropathy".

神经病的诊断：对“周围神经病初步评估中的测试和支出”的评论。

• DOI: 10.1001/archinternmed.2011.1718
• 发表时间: 2012
• 期刊: Archives of internal medicine
• 作者: Smith,AGordon

SMA valiant trial: a prospective, double-blind, placebo-controlled trial of valproic acid in ambulatory adults with spinal muscular atrophy.

• DOI: 10.1002/mus.23904
• 发表时间: 2014-02
• 期刊: MUSCLE & NERVE
• 影响因子: 3.4
• 作者: Kissel, John T.;Elsheikh, Bakri;King, Wendy M.;Freimer, Miriam;Scott, Charles B.;Kolb, Stephen J.;Reyna, Sandra P.;Crawford, Thomas O.;Simard, Louise R.;Krosschell, Kristin J.;Acsadi, Gyula;Schroth, Mary K.;D'Anjou, Guy;LaSalle, Bernard;Prior, Thomas W.;Sorenson, Susan;Maczulski, Jo Anne;Swoboda, Kathryn J.
• 通讯作者: Swoboda, Kathryn J.