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

迫切需要将新的临床前数据快速转化为各种神经疾病患者的新疗法。神经科学临床试验卓越网络(NEXT)由NINDS于2011年建立，旨在开发和进行第二阶段临床试验和生物标记物验证研究。西北大学(NU)范伯格医学院(NUFSM)自成立以来一直是该联盟积极和有效的成员。这个应用程序是为了响应NINDS RFA而开发的，以便在下一步继续作为临床站点参与。NU NEXT中心是一项合作努力，旨在协调三家主要NUFSM医院的师资和资源：西北纪念医院(NMH)，在网络中有11家医院，Lurie儿童医院(LCH)和雪莉·瑞安能力实验室(SRALab)。NCTC的教职员工由高技能的临床研究人员组成，他们拥有所有神经学亚专业的专业知识，并能够接触到具有各种神经疾病的多样化和有良好特征的成人和儿科人群的庞大患者基础。正如我们在上一个资助期中所证明的那样，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记物验证研究的开发和成功完成做出贡献。这些关键人员在各自专业的临床和转化性研究方面拥有丰富的经验；在主要研究项目(包括NINDS资助的项目)中担任领导角色；在前沿合作项目方面的记录，尤其是在基因传递和治疗研究方面的经验；接触到大量和多样化的神经系统疾病患者；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下一项和其他临床试验。我们西北大学临床与转化科学研究所(NUCATS)在NIH资助的临床与转化科学奖(CTSA)的支持下建立的基础设施以及我们的部门临床试验中心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口在内的NEXT项目所需的所有必要资源、设施和设备。有一个强有力的机构重点是增加研究参与者和研究团队的多样性。在培训下一代临床医生调查人员方面，有广泛的专业知识和成功的记录。NU Next中心的参与将使NU Next中心能够继续为成人和儿科人群中多个亚专业的神经临床试验提供专业知识和研究参与者，整合跨学科的努力，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职业生涯。

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.