Clinical Research Sites for the Network of Excellence in Neuroscience Clinical Trials (NEXT Sites)

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治疗方法。神经科学临床试验卓越网络（NEXT）由NINDS于2011年建立，目的是开发和开展2期临床试验和生物标志物验证研究。这个网络非常成功。西北大学（NU）范伯格医学院（NUFSM）的神经病学临床试验中心（NCTC）一直是该联盟的积极和有效的成员。本申请是为响应NINDS RFA而开发的，以继续我们作为NEXT临床站点的参与。西北纪念医院（NMH）、芝加哥Lurie儿童医院（LCH）和雪莉·瑞安能力实验室（SRALab），即以前的芝加哥康复研究所（RIC），是NU NCTC的一项合作努力，协调了NUFSM三家主要医院的教师和资源。NCTC的教职员工由高技能的临床医师调查员组成，他们具有所有神经学亚专业的专业知识，并且可以接触到患有各种神经系统疾病的不同且特征鲜明的成人和儿科人群。正如我们在初始资助期所展示的那样，NU NCTC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。核心人员在各自的专科拥有丰富的临床和转化研究经验；在重大研究项目（包括国家科学研究院资助项目）中发挥领导作用；前沿合作项目的跟踪记录；为大量不同的神经系统疾病患者提供服务；在NEXT和其他由NIH、私人基金会和行业赞助的临床试验中成功招募患者和对照受试者。由美国国立卫生研究院资助的临床与转化科学奖（CTSA）和我们部门的NCTC支持的西北大学临床与转化科学研究所（NUCATS）的既定基础设施将继续确保我们中心及时招募受试者。学校NCTC拥有继续支持NEXT项目所需的所有资源、设施和设备。此外，在设计和执行未来NEXT项目的转化研究方面，NU有大量的专业知识，自最初提交以来已经大大增加。参与NEXT将使NCTC能够为成人和儿童人群的神经学临床试验做出贡献，巩固各部门的努力，并为初级研究人员提供培训，使他们能够发展独立的研究事业。

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. The network has been highly successful. The Neurology Clinical Trials Center (NCTC) at Northwestern University's (NU) Feinberg School of Medicine (NUFSM) has been an active and effective member of the consortium. This application has been developed in response to the NINDS RFA to continue our participation as a Clinical Site in the NEXT. The NU NCTC is a collaborative effort that coordinates faculty and resources of three major NUFSM hospitals: Northwestern Memorial Hospital (NMH), Lurie Children's Hospital of Chicago (LCH) and the Shirley Ryan AbilityLab (SRALab), formerly Rehabilitation Institute of Chicago (RIC). 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 initial funding period, the NU NCTC 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; access to large and diverse populations of patients with neurological conditions; and success in enrolling patients and control subjects 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 NCTC will continue to assure timely subject recruitment by our Center. The NU NCTC has all required resources, facilities and equipment necessary to continue to support NEXT projects. In addition, there is substantial expertise at NU that has grown substantially since the original submission in the design and execution of translational studies for future NEXT projects. Participation in NEXT will allow NCTC to contribute to the neurological clinical trials across the subspecialties in adult and pediatric population, consolidate the effort across the divisions and provide training for the junior investigators that will enable them to develop independent research careers.