UTSW Clinical Research Site for Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT)

UTSW 神经科学临床试验卓越网络临床研究网站 (NeuroNEXT)

• 批准号: 9571862
• 负责人: Mark Paul Goldberg
• 金额: $ 32.4万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-15 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9571862
• 关键词: Adult; African American; Area; Brain; Caring; Catchment Area; Center for Translational Science Activities; Child; Clinical; Clinical Research; Clinical Trials; Clinical and Translational Science Awards; Clinics and Hospitals; Collaborations; Communities; Community Outreach; Data Quality; Databases; Development; Disease; Educational Curriculum; Enrollment; Ensure; Equipment; Expenditure; Faculty; Funding; Future; Goals; Health; Health Resources; Health system; Hispanic Americans; Hospitals; Human Resources; Institutes; Institution; Integrated Health Care Systems; Leadership; Medical center; Mentorship; Nervous system structure; Neurology; Neurosciences; Neurosciences Research; Patient Recruitments; Patients; Pediatric Hospitals; Pediatric Neurology; Pediatrics; Performance; Population; Population Heterogeneity; Process; Psychiatry; Publications; Rehabilitation therapy; Research; Research Infrastructure; Research Personnel; Research Support; Research Training; Resources; Services; Site; Speed; Structure; Talents; Texas; Time; Training; Training Programs; Training Support; Translating; United States; United States National Institutes of Health; Universities; University Hospitals; academic program; career development; clinical data warehouse; clinical research site; collaborative environment; data warehouse; expectation; experience; improved; innovation; medical specialties; member; metropolitan; multidisciplinary; nervous system disorder; neurosurgery; operation; professor; programs; recruit; screening; success; tool; translational medicine; translational neuroscience

This is an application for competitive renewal of UT Southwestern Medical Center (UTSW) as a clinical research site for the Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT). The project continues to be led by Drs. Mark Goldberg and Susan Iannaccone, who bring experience in program leadership with complementary areas of expertise in adult and pediatric neurology, respectively. The project has demonstrated enrollment and operational successes in the initial funding period. UTSW is one of the few sites selected to participate in all eight funded studies by the network (NN109 site selection is still underway). We are among the top five enrolling sites and have met or exceeded network averages for patient recruitment, retention, timeliness, data quality and accuracy metrics. We propose to expand on these successes in the next cycle. First, we will take advantage of new institutional relationships to expand the number of patients available for screening and enrollment. UTSW has partnered with a large health network, Texas Health Resources, to create an integrated health system of 31 hospitals and clinics called the Southwestern Health Resources (SWHR). Altogether, our collaborative research relationships with community care partners and health systems brings potential enrollment access to almost three quarters of the Dallas-Fort Worth metroplex. In addition, the newly formed Peter O’Donnell Jr. Brain Institute at UTSW brings together several departments and centers focused on the study of the nervous system under a multi-disciplinary, collaborative umbrella. Second, we will make use of innovative research resources to improve the speed, efficiency, and quality of clinical trials. With the initial launch of NeuroNEXT, we established the Neuroscience Translational Research Center (NTRC), which provides core services, dedicated research space, equipment, regulatory expertise, and trained personnel for NIH and other studies across the clinical neurosciences. This resource has grown in scope and quality, and will be further enhanced with improved database support, an expanded institutional EMR-to-research data warehouse, and new online tools for patient recruitment and enrolment. Third, we will implement a clinical research curriculum, taking advantage of existing resources for early stage investigators (ESI) in collaboration with the Center for Translational Medicine (CTM) at UTSW. We have had ESIs serve as study PIs on six of the eight NeuroNEXT studies, proving our commitment to early career development. We will continue provide structured curriculum with clinical research mentorship to several candidates from our talented pool of ESIs.

这是UT西南医学中心（UTSW）的竞争更新的申请，作为神经科学临床试验卓越网络（Neuronext）的临床研究站点。该项目继续由Drs领导。马克·戈德堡（Mark Goldberg）和苏珊·伊安纳克（Susan Iannaccone）分别在成人和儿科神经病学专家领域中带来了计划领导力的经验。该项目在最初的资金期间表明了入学和运营成功。 UTSW是被选为网络参与所有八项资助研究的少数网站之一（NN109站点选择仍在进行中）。我们是前五名的入学站点之一，并且已经达到或超过网络平均值，用于招募患者，保留，及时性，数据质量和准确性指标。我们建议在下一个周期中扩展这些成功。首先，我们将利用新的机构关系来扩大可供筛查和入学率的患者数量。 UTSW与大型健康网络Dexas Health Resources合作，创建了一个综合的卫生系统，该系统由31家医院和诊所组成，称为西南卫生资源（SWHR）。总的来说，我们与社区护理合作伙伴和卫生系统的合作研究关系为达拉斯 - 沃思 - 沃思 - 沃思 - 沃思 - 沃思 - 沃思 - 沃思 - 沃思 - 沃思 - 沃思 - 沃思 - 沃思 - 沃思 - 沃思 - 沃思 - 沃思 - 沃思 - 沃思 - 沃思 - 沃思 - 沃思 - 沃思 - 沃思 - 沃思 - 沃思 - 沃思 - 沃斯特（Dalloplex）的卫生系统的合作关系。此外，UTSW的新成立的彼得·奥唐纳尔（Peter O’Donnell Jr.其次，我们将利用创新的研究资源来提高临床试验的速度，效率和质量。随着Neuronext的最初推出，我们建立了神经科学转化研究中心（NTRC），该中心提供了核心服务，专门的研究空间，设备，监管专业知识以及培训的NIH和其他临床神经科学研究的培训人员。该资源在范围和质量方面已增长，并通过改进的数据库支持，扩展的机构EMR到研究数据仓库以及用于患者招聘和增强的新的在线工具而进一步增强。第三，我们将在UTSW与转化医学中心（CTM）合作，利用现有的早期研究人员（ESI）来实施临床研究课程。我们曾在八个Neuronext研究中的六个研究中充当研究PI，这提供了我们对早期职业发展的承诺。我们将继续向我们才华横溢的ESI库中的几个候选人提供结构化课程。