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

Clinical Research Sites for the Network of Excellence in Neuroscience Clinical Trials (NEXT Sites)
神经科学临床试验卓越网络的临床研究站点(NEXT 站点)
批准号:
10447736
负责人:
Tanya Simuni
金额:
$33.22万
依托单位国家:
美国
项目类别:
财政年份:
2018
资助国家:
美国
项目状态:
已结题
起止时间:
2018-07-01 至 2023-07-31

项目摘要

项目成果

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中文摘要
翻译
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。该网络一直非常成功。西北大学范伯格医学院(NUFSM)的神经学临床试验中心(NCTC)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 NCTC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)、芝加哥Lurie儿童医院(LCH)和雪莉·瑞安能力实验室(SRALab),即前芝加哥康复研究所(RIC)。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。正如我们在最初的资助期所证明的那样,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;尖端合作项目的跟踪记录;接触到大量和多样化的神经系统疾病患者;成功地招募患者和对照对象参加由NIH、私人基金会和行业来源赞助的下一次和其他临床试验。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)和我们的部门NCTC的支持下建立的基础设施将继续确保我们中心及时招募学科。NU NCTC拥有继续支持NEXT项目所需的所有必要资源、设施和设备。此外,NU在为未来的NEXT项目设计和执行翻译研究方面拥有大量的专业知识,自最初提交以来已有显著增长。参与NEXT将使NCTC能够为成人和儿科人口中跨专业的神经学临床试验做出贡献,巩固跨部门的努力,并为初级调查人员提供培训,使他们能够发展独立的研究生涯。
英文摘要
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.
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