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3项试验，其中第4项完成了开放标签扩展；另外3个正在注册，1个将于11月17日开始注册，1个刚刚获得资助。4名已完成注册的学生均提前或提前完成了注册。每个共享快速启动和优秀的数据准确性/质量。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5个州提供服务的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。初级儿童医疗中心（PCMC）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医疗中心（SLCVAMC）， VISN 19的锚定中心和Shriners儿童医院。UR-NEXT基本上可以接触到该地区的所有患者（800万覆盖生命）。山间医疗保健（IHC）是最大的医疗保健系统，与UUH合作运营PCMC，是一个重要的研究伙伴。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得益于与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，并同意继续为NeuroNEXT这样做。在第一个资助期内，UR-NEXT高度参与并取得了成功，参与了7/8的研究，这些研究已经进行了选址（并自愿参加了nN109）。UR-NEXT一直是注册率最高的网站之一，也是启动时间最快的网站之一。Smith博士，UR-NEXT PI，也是NN108的PI，隐源性感觉神经病变的托吡酯（TopCSPN研究），以及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，该奖学金将授予对临床试验感兴趣的有前途的早期职业教师研究者。该项目将受益于CCTS、TIC和副校长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.