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

这是德克萨斯大学西南医学中心(UTSW)作为神经科学临床试验卓越网络(NeuroNEXT)的临床研究站点的竞争续签申请。该项目继续由Mark Goldberg博士和Susan Iannaccon博士领导，他们带来了项目领导方面的经验，分别在成人神经学和儿科神经学方面具有互补的专业知识。该项目在最初的筹资期间取得了招生和运作方面的成功。UTSW是少数几个被选中参与该网络资助的所有八项研究的地点之一(NN109地点的选择仍在进行中)。我们是前五大注册网站之一，在患者招募、留住、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供筛查和登记的患者数量。UTSW已与大型医疗网络德克萨斯医疗资源公司合作，创建了一个由31家医院和诊所组成的综合医疗系统，称为西南医疗资源(SWHR)。总而言之，我们与社区护理合作伙伴和医疗系统的合作研究关系为达拉斯-沃斯堡大都市中心近四分之三的地区带来了潜在的登记机会。此外，新成立的小彼得·奥唐奈。加州大学旧金山分校的脑研究所将几个专注于神经系统研究的部门和中心聚集在一个多学科的协作保护伞下。二是利用创新研究资源，提高临床试验速度、效率和质量。随着NeuroNEXT的成立，我们成立了神经科学翻译研究中心(NTRC)，为NIH和其他临床神经科学研究提供核心服务、专门的研究空间、设备、监管专业知识和培训人员。这一资源的范围和质量已经扩大，并将通过改进的数据库支持、扩大的机构电子病历到研究的数据仓库以及病人招募和登记的新在线工具而得到进一步加强。第三，我们将与UTSW的转化医学中心(CTM)合作，利用现有的早期调查人员(ESI)资源，实施临床研究课程。在NeuroNEXT的八项研究中，我们有六项让Esis担任研究PI，证明了我们对早期职业发展的承诺。我们将继续从我们的人才库中为几名候选人提供结构化的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.