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

神经科学临床试验卓越网络临床研究网站（NeuroNEXT 网站）

• 批准号: 10744891
• 负责人: Tanya Simuni
• 金额: $ 45.13万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 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 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10744891
• 关键词: Adherence; Adult; Agreement; Chicago; Childhood; Clinical; Clinical Research; Clinical Sciences; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Clinical and Translational Science Awards; Conduct Clinical Trials; Data; Development; Discipline; Enrollment; Ensure; Equipment; Faculty; Foundations; Funding; Future; Gender; Gene Delivery; Hospitals; Human Resources; Industry; Infrastructure; Institution; Institutional Review Boards; Intervention Trial; Leadership; Mentorship; Minority; Modeling; National Institute of Neurological Disorders and Stroke; Neurologic; Neurology; Neurosciences; Participant; Patient Recruitments; Patients; Pediatric Hospitals; Performance; Phase; Phase II Clinical Trials; Population; Population Heterogeneity; Privatization; Protocols documentation; Qualifying; Reporting; Research; Research Personnel; Research Project Grants; Research Training; Resources; Role; Site; Source; Standardization; Structure; Training; Translational Research; Translations; United States National Institutes of Health; Universities; Work; base; biomarker validation; career; clinical biomarkers; clinical research site; data quality; design; experience; gene therapy; human subject protection; industry partner; medical schools; member; nervous system disorder; next generation; novel; participant enrollment; participant retention; patient oriented; patient population; pre-clinical; programs; recruit; response; skills; success; translational study; validation studies; working group

There is a critical need for rapid translation of novel preclinical data into new treatments for patients with a variety of neurological diseases. The Network for Excellence in Neuroscience Clinical Trials (NEXT) was established by NINDS in 2011 with the objective to develop and conduct Phase 2 clinical trials and biomarker validation studies. Northwestern University’s (NU) Feinberg School of Medicine (NUFSM) has been an active and effective member of the consortium since inception. This application has been developed in response to the NINDS RFA to continue our participation as a Clinical Site in the NEXT. The NU NEXT Center is a collaborative effort that coordinates faculty and resources of three major NUFSM hospitals: Northwestern Memorial Hospital (NMH) with 11 hospitals in the network, Lurie Children’s Hospital (LCH) and the Shirley Ryan Ability Lab (SRALab). The NCTC faculty is comprised of highly skilled clinician investigators with expertise across all neurological subspecialties and access to a large patient base of diverse and well characterized adult and pediatric populations with a variety of neurological diseases. As we have demonstrated in the prior funding period, the NU NEXT Center is highly qualified to continue to participate in NEXT and to contribute to the development and successful completion of the network clinical trials and biomarker validation studies. The key personnel have extensive experience in clinical and translational research in their respective subspecialties; leadership roles in major research programs (including NINDS-funded projects); track record of cutting edge collaborative projects, importantly, experience in gene delivery and therapy studies; access to large and diverse populations of patients with neurological conditions; and success in enrolling patients and control participants in the NEXT and other clinical trials sponsored by NIH, private foundations and industry sources. The established infrastructures of our Northwestern University Clinical and Translational Sciences Institute (NUCATS) supported by NIH funded Clinical and Translational Science Award (CTSA) and our departmental Clinical Trials center will continue to assure timely participants recruitment by our Center. The NU NEXT Center has all required resources, facilities and equipment necessary to continue to support and actively participate in NEXT projects including pediatric population. There is a strong institutional emphasis to increase diversity of the research participants and research teams. There is extensive expertise and track record of success in training the next generation of clinician investigators. Participation in NEXT will enable the NU NEXT Center to continue to contribute expertise and research participants to neurological clinical trials across multiple subspecialties in adult and pediatric populations, consolidate efforts across disciplines, and to further expand training for junior investigators to enable them to develop independent research careers.

目前迫切需要将新的临床前数据快速转化为各种神经系统疾病患者的新治疗方法。神经科学临床试验卓越网络（NEXT）由NINDS于2011年建立，旨在开发和开展2期临床试验和生物标志物验证研究。西北大学（NU）Feinberg医学院（NUFSM）自成立以来一直是该联盟的积极有效成员。该应用程序是为响应NINDS RFA而开发的，以继续作为临床研究中心参与NEXT。NU NEXT中心是一个协调三家主要NUFSM医院的教师和资源的协作努力：西北纪念医院（NMH）与网络中的11家医院，Lurie儿童医院（LCH）和Shirley Ryan能力实验室（SRALab）。NCTC的教师是由高技能的临床研究人员与专业知识，在所有神经亚专业和访问不同的和良好的特征成人和儿童人群与各种神经系统疾病的大型患者基础。正如我们在上一个资助期所证明的那样，NU NEXT中心非常有资格继续参与NEXT，并为网络临床试验和生物标志物验证研究的开发和成功完成做出贡献。主要人员在各自的子专业中具有丰富的临床和转化研究经验;在主要研究项目中担任领导角色（包括NINDS资助的项目）;尖端合作项目的跟踪记录，重要的是，在基因传递和治疗研究方面的经验;接触大量不同的神经系统疾病患者群体;以及成功招募患者和对照参与者参加由NIH、私人基金会和行业来源赞助的NEXT和其他临床试验。我们西北大学临床和转化科学研究所（NUCATS）的基础设施由NIH资助的临床和转化科学奖（CTSA）和我们的部门临床试验中心支持，将继续确保我们中心及时招募参与者。NU NEXT中心拥有继续支持和积极参与包括儿科人群在内的NEXT项目所需的所有资源、设施和设备。有一个强大的机构强调增加研究参与者和研究团队的多样性。在培训下一代临床研究人员方面拥有广泛的专业知识和成功的记录。参与NEXT将使NU NEXT中心能够继续为成人和儿科人群的多个亚专业的神经学临床试验提供专业知识和研究参与者，巩固跨学科的努力，并进一步扩大对初级研究人员的培训，使他们能够发展独立的研究事业。