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)
批准号:
10163924
负责人:
Tanya Simuni
金额:
$33.75万
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 2023-06-30
关键词:
AdherenceAdultAgreementChicagoChildhoodClinicalClinical ResearchClinical SciencesClinical TrialsClinical Trials DesignClinical Trials NetworkClinical and Translational Science AwardsConduct Clinical TrialsDataDatabase Management SystemsDevelopmentDisciplineEnrollmentEnsureEquipmentFacultyFoundationsFundingFutureGenderHospitalsHuman ResourcesIndustryInformed ConsentInfrastructureInstitutesInstitutional Review BoardsIntervention TrialLeadershipMentorshipMinorityModelingNational Institute of Neurological Disorders and StrokeNeurologicNeurologyNeurosciencesOnline SystemsPatientsPediatric HospitalsPerformancePhasePhase II Clinical TrialsPopulationPopulation HeterogeneityPrivatizationProtocols documentationRehabilitation therapyReportingResearchResearch PersonnelResearch Project GrantsResearch SubjectsResourcesRoleSiteSourceStandardizationStructureTimeTrainingTranslational ResearchTranslationsUnited States National Institutes of HealthUniversitiesWorkbasebiomarker validationcareerclinical biomarkersclinical research sitedata qualitydesignexperiencehuman subject protectionmedical schoolsmembernervous system disordernovelpatient orientedpatient populationpre-clinicalprogramsrecruitresponsesuccesstranslational studyvalidation studiesworking group
中文摘要
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。该网络非常成功。西北大学(NU)Feinberg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 NCTC是一个协调三家主要NUFSM医院的教师和资源的合作努力:西北纪念医院(NMH),芝加哥Lurie儿童医院(LCH)和Shirley Ryan AbilityLab(SRALab),前身为芝加哥康复研究所(RIC)。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。正如我们在最初的资助期间所证明的那样,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;接触大量不同的神经系统疾病患者;以及成功招募患者和对照受试者参加由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NCTC支持,将继续确保我们中心及时招募受试者。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,有大量的专业知识在NU,已经大幅增长,因为在未来NEXT项目的翻译研究的设计和执行的原始提交。参与NEXT将使NCTC能够为成人和儿科人群的亚专业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。
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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Clinical Research Sites for the Network of Excellence in Neuroscience Clinical Trials (NEXT Sites)
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批准号:9570126
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项目类别:
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资助金额:$33.51万
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财政年份:2018
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负责人:Tanya Simuni
-
依托单位:
Clinical Research Site for the Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT site)
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批准号:10744891
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项目类别:
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资助金额:$45.13万
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财政年份:2018
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负责人:Tanya Simuni
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依托单位:
Clinical Research Sites for the Network of Excellence in Neuroscience Clinical Trials (NEXT Sites)
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批准号:10447736
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项目类别:
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资助金额:$33.22万
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财政年份:2018
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负责人:Tanya Simuni
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依托单位:
Clinical Coordination Center for STEADY-PD3
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批准号:8629209
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项目类别:
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资助金额:$273.01万
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财政年份:2014
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负责人:Tanya Simuni
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依托单位:
Clinical Coordination Center for STEADY-PD3
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批准号:9038462
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项目类别:
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资助金额:$358.53万
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财政年份:2014
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负责人:Tanya Simuni
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依托单位:
Clinical Coordination Center for STEADY-PD3
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批准号:9247852
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项目类别:
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资助金额:$240.15万
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财政年份:2014
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负责人:Tanya Simuni
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依托单位:
Clinical Research Sites for the Network of Excellence in Neuroscience Clinical Tr
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批准号:9102283
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项目类别:
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资助金额:$30.21万
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财政年份:2011
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负责人:Tanya Simuni
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依托单位:
Clinical Research Sites for the Network of Excellence in Neuroscience Clinical Tr
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批准号:8240651
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项目类别:
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资助金额:$31.61万
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财政年份:2011
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负责人:Tanya Simuni
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依托单位:
Clinical Research Sites for the Network of Excellence in Neuroscience Clinical Tr
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批准号:8337818
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项目类别:
-
资助金额:$29.21万
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财政年份:2011
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负责人:Tanya Simuni
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依托单位:
Clinical Research Sites for the Network of Excellence in Neuroscience Clinical Tr
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批准号:9293389
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项目类别:
-
资助金额:$30.21万
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财政年份:2011
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负责人:Tanya Simuni
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依托单位:
Clinical Research Sites for the Network of Excellence in Neuroscience Clinical Tr
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批准号:8533046
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项目类别:
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资助金额:$20.77万
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财政年份:2011
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负责人:Tanya Simuni
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依托单位:
Parkinson's Disease Neuroprotection Trial
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批准号:7233702
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项目类别:
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资助金额:$4.37万
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财政年份:2006
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负责人:Tanya Simuni
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依托单位:
Neuroprotection Exploratory Trials in Parkinson's Disease (NET-PD)
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批准号:8601337
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项目类别:
-
资助金额:$0.92万
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财政年份:2006
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负责人:Tanya Simuni
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依托单位:
Parkinson's Disease Neuroprotection Trial
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批准号:7787094
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项目类别:
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资助金额:$9.31万
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财政年份:2006
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负责人:Tanya Simuni
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依托单位:
Parkinson's Disease Neuroprotection Trial
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批准号:7558543
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项目类别:
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资助金额:$11.26万
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财政年份:2006
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负责人:Tanya Simuni
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依托单位:
Parkinson's Disease Neuroprotection Trial
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批准号:8242316
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项目类别:
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资助金额:$14.44万
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财政年份:2006
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负责人:Tanya Simuni
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依托单位:
Neuroprotection Exploratory Trials in Parkinson's Disease (NET-PD)
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批准号:8459668
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项目类别:
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资助金额:$6.41万
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财政年份:2006
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负责人:Tanya Simuni
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依托单位:
Parkinson's Disease Neuroprotection Trial
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批准号:7351799
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项目类别:
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资助金额:$10.21万
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财政年份:2006
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负责人:Tanya Simuni
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依托单位:
Parkinson's Disease Neuroprotection Trial
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批准号:7011783
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项目类别:
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资助金额:$3.01万
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财政年份:2006
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负责人:Tanya Simuni
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依托单位:
海外基金