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

这是 UT 西南医学中心 (UTSW) 作为神经科学临床试验卓越网络 (NeuroNEXT) 临床研究中心的竞争性更新申请。该项目继续由博士领导。马克·戈德伯格 (Mark Goldberg) 和苏珊·伊纳科恩 (Susan Iannaccone) 分别带来了项目领导经验以及成人和儿科神经病学领域互补的专业知识。该项目在初始资助期间已展现出注册和运营方面的成功。 UTSW 是少数被选中参与该网络所有八项资助研究的站点之一（NN109 站点选择仍在进行中）。我们是排名前五的注册网站之一，在患者招募、保留、及时性、数据质量和准确性指标方面达到或超过了网络平均水平。我们建议在下一个周期扩大这些成功。首先，我们将利用新的机构关系来扩大可用于筛查和登记的患者数量。 UTSW 与大型医疗网络 Texas Health Resources 合作，创建了一个由 31 家医院和诊所组成的综合医疗系统，称为 Southwestern Health Resources (SWHR)。总而言之，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-沃斯堡大都市近四分之三的地区带来了潜在的入学机会。此外，UTSW 新成立的 Peter O’Donnell Jr. 脑研究所汇集了多个部门和中心，在多学科协作的框架下专注于神经系统的研究。二是利用创新研究资源，提高临床试验的速度、效率和质量。随着 NeuroNEXT 的首次推出，我们建立了神经科学转化研究中心 (NTRC)，该中心为 NIH 和临床神经科学领域的其他研究提供核心服务、专用研究空间、设备、监管专业知识和训练有素的人员。该资源的范围和质量不断扩大，并将通过改进的数据库支持、扩大的机构 EMR 到研究数据仓库以及用于患者招募和登记的新在线工具进一步增强。第三，我们将与 UTSW 转化医学中心 (CTM) 合作，利用早期研究人员 (ESI) 的现有资源，实施临床研究课程。我们已让 ESI 作为 8 项 NeuroNEXT 研究中的 6 项的研究 PI，证明了我们对早期职业发展的承诺。我们将继续为 ESI 人才库中的几位候选人提供结构化课程和临床研究指导。

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.