Clinical Research Sites for the Network of Excellence in Neuroscience Clinical Tr

神经科学临床研究卓越网络的临床研究网站

• 批准号: 8337818
• 负责人: Tanya Simuni
• 金额: $ 29.21万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-30 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8337818
• 关键词: Adult; Agreement; Award; Basic Science; Biological Markers; Chicago; Childhood; Clinical; Clinical Research; Clinical Sciences; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Community Networks; Conduct Clinical Trials; Data; Development; Discipline; Disease; Enrollment; Ensure; Equipment; Faculty; Foundations; Funding; Future; Growth; Hospitals; Human Resources; Industry; Institutes; Institutional Review Boards; Ions; Knowledge; Leadership; Low Prevalence; Mentorship; Modeling; National Institute of Neurological Disorders and Stroke; Neurologic; Neurology; Neurosciences; Outcome; Patients; Pediatric Hospitals; Phase II Clinical Trials; Population; Population Heterogeneity; Preclinical Testing; Qualifying; Records; Recruitment Activity; Rehabilitation therapy; Research; Research Infrastructure; Research Personnel; Research Project Grants; Research Subjects; Resources; Role; Site; Source; Spinal Muscular Atrophy; Structure; Therapeutic; Training; Translational Research; Translations; United States National Institutes of Health; Universities; Work; base; career; clinical research site; design; experience; medical schools; nervous system disorder; novel; patient population; pre-clinical; programs; research study; response; success; translational study; validation studies

DESCRIPTION (provided by applicant): There is a critical need for rapid translation of novel preclinical data into new treatments for patients with a variety of neurological diseases. Despite exponential growth of basic science knowledge, there has been only limited translation of new findings into therapeutics. There are multiple reasons that fewer than 1 in 250 molecules that undergo preclinical testing are ultimately approved for clinical use; one important factor is the difficulty in recruiting subjects who have diseases of low prevalence. This application has been developed in response to the NINDS RFA to participate as a Clinical Site in the Network for Excellence in Neuroscience Clinical Trials (NEXT). The Neurology Clinical Trials Center (NCTC) at Northwestern University's Feinberg School of Medicine (NUFSM) is a collaborative effort that coordinates faculty and resources of three major Northwestern-University-affiliated clinical facilities: Northwestern Memorial Hospital (NMH), Children's Memorial Hospital (CMH) and the 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. The NCTC is uniquely qualified 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 records 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 research studies and 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 an NIH-funded Clinical and Translational Science Award (CTSA) and our departmental NCTC will assure timely subject recruitment by our Center. The NCTC also has a critical mass of investigators with expertise in spinal muscular atrophy (SMA) research and access to SMA pediatric and adult populations. The NCTC has all of the required resources and equipment necessary to support NEXT projects. In addition, there is substantial expertise at Northwestern University (NU) in the design and execution of translational studies for future NEXT projects. Participation in NEXT will enable the NCTC to contribute expertise and research subjects to neurological clinical trials across multiple subspecialties in adult and pediatric populations, consolidate efforts across disciplines, and provide training for junior investigators to enable them to develop independent research careers.

描述(由申请人提供)：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。尽管基础科学知识呈指数级增长，但将新发现转化为治疗学的情况有限。有多个原因导致经过临床前测试的分子中只有不到1个最终被批准用于临床；一个重要的因素是很难招募到患有低发病率疾病的受试者。此应用程序是为了响应NINDS RFA作为神经科学临床试验卓越网络(NEXT)的临床站点而开发的。西北大学范伯格医学院(NUFSM)的神经学临床试验中心(NCTC)是一项合作努力，旨在协调西北大学附属三大临床机构的师资和资源：西北纪念医院(NMH)、儿童纪念医院(CMH)和芝加哥康复研究所(RIC)。NCTC的教职员工由高技能的临床医生研究员组成，他们拥有所有神经病学亚专业的专业知识，并能够接触到 患者群体多样且具有良好特征的成人和儿科人群患有各种神经疾病。NCTC是唯一有资格参与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的机构。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；前沿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研究研究和临床试验。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部门的NCTC将确保我们中心及时招募学科。NCTC还拥有一批在脊髓性肌萎缩症(SMA)研究和接触SMA儿童和成人人口方面具有专业知识的研究人员。国家反恐中心拥有支持下一个项目所需的所有资源和设备。此外，西北大学(NU)在为未来的NEXT项目设计和执行翻译研究方面拥有丰富的专业知识。参与NEXT将使NCTC能够为成人和儿科人群中多个亚专业的神经学临床试验贡献专业知识和研究课题，整合跨学科的努力，并为初级研究人员提供培训，使他们能够发展独立的研究生涯。