State University of New York (SUNY) NEXT Clinical Site
State University of New York (SUNY) NEXT Clinical Site
批准号:
9104230
负责人:
STEVEN Richard LEVINE
金额:
$30.1万
依托单位国家:
美国
项目类别:
财政年份:
2011
资助国家:
美国
项目状态:
已结题
起止时间:
2011-09-30 至 2018-06-30
关键词:
AdultAffectAmericanChildhoodClinicalClinical InvestigatorClinical ResearchClinical TrialsClinical Trials DesignClinical Trials NetworkClinical trial protocol documentClinics and HospitalsCommunitiesCommunity HospitalsConduct Clinical TrialsData Coordinating CenterDevelopmentDiseaseEthicsFoundationsFundingGoalsGrantHealthHospitalsImProvIndustryInstitutesLeadershipLocal GovernmentMedicalMentorsMorbidity - disease rateNational Institute of Neurological Disorders and StrokeNeurologicNeurologyNeurosciencesNew YorkParticipantPatient RecruitmentsPatientsPerformancePhase III Clinical TrialsPopulationPopulation HeterogeneityProtocols documentationPublic HealthRecruitment ActivityResearchResearch InfrastructureResearch PersonnelResourcesRuralSiteSpecialistState GovernmentStructureTelemedicineTestingTrainingTranslational ResearchTranslationsUnderrepresented MinorityUnited States National Institutes of HealthUniversitiesWorkbaseclinical research sitecommunity centercommunity partnershipeffective therapyexperiencegeographic populationimprovedinnovationminority investigatormortalitynervous system disorderorganizational structurepatient advocacy grouppatient populationracial and ethnicresponsesuccess
中文摘要
描述(由申请人提供):纽约州立大学(SUNY)响应NINDS RFA的申请,作为神经科学卓越临床试验网络(NEXT)的临床站点参与。我们汇集了4个纽约州立大学学术健康中心(AHC),它们的本地和多样化社区,以及它们与行业、医院和诊所网络的联系。这将确保一个强大和可访问的基础设施,以促进快速制定和实施影响成人和儿科人群的神经疾病方案。通过将4个纽约州立大学校区整合到一个应用程序中,我们创建了一个创新的、非常庞大的患者网络,这些患者具有极其多样化的民族和种族背景,这将促进对神经学临床试验性能的持续和强大影响,从而更快地进入三期试验。在过去的几年中,纽约州立大学跨校园项目的成功势头急剧增加,主要领导通过机构的硬钱和赠款形成并支持纽约州立大学REACH的形成。现在,在纽约州立大学的REACH中,神经系统疾病得到了重要的支持和合作活动,纽约州立大学的NEXT提案将进一步加强基础设施并扩大我们的纽约州立大学临床试验网络。我们已经建立了这个网络,并继续完善它,以提供全面的疾病特异性专业知识(成人和儿科神经专家和亚专科专家)、临床试验专业知识和经验(包括试验协调员)、临床/转化研究基础设施、机构承诺以及正在进行/扩大的社区咨询和研究。我们的网络可以协调一个庞大的、地理位置不同的专家调查骨干,有效地实施研究,以应对特定疾病的机会。我们还有一组初级/新临床试验人员,包括代表性不足的少数民族研究人员,我们将对他们进行神经病学临床试验的培训。鉴于我们在远程医疗方面的专业知识和连接性,我们将探索在与纽约州立大学附属的更偏远、更小的地点进行临床试验的可行性,以获得更多的美国农村人参加临床试验。我们的成功将改变协作构建临床试验的模式,并最终改善公共卫生。
英文摘要
DESCRIPTION (provided by applicant): This application from the State University of New York (SUNY) responds to the NINDS RFA to participate as a Clinical Site in the Network for Excellence in Neuroscience Clinical Trials (NEXT). We have brought together the 4 SUNY Academic Health Centers (AHC), their local and diverse communities, and their liaisons with industry and hospital and clinic networks. This will insure a robust and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and pediatric populations. By combining 4 SUNY campuses into one application, we have created an innovative and very large network of patients with extremely diverse ethnic and racial backgrounds that will facilitate a sustained and powerful influence on neurological clinical trial performance leading to a faster pipeline to phase 3 trials. Momentum for successful SUNY cross-campus projects has increased dramatically over the past several years with key leadership forming and supporting the formation of SUNY REACH via institutional hard dollars and grants. There is now significant support and collaborative activities for neurological diseases within the SUNY REACH and this SUNY NEXT proposal will further enhance infrastructure and expand our SUNY Clinical Trials Network. We have built this network and continue to refine it to provide a comprehensive array of disease-specific expertise (adult and pediatric neurologic specialists and subspecialists), clinical trial expertise and experience including trial coordinators, clinical/translational research infrastructure, institutional commitment, and ongoing/expanding community-based advice and research. Our network can coordinate a large, geographically diverse cadre of specialist investigators to implement studies efficiently in response to disease-specific opportunities. We also have a group of junior/new clinical trialists, including under-represented minority investigators, who we will train in the performance of neurology clinical trials. We will explore, given our expertise and connectivity in telemedicine, the feasibility of performing clinical trials to more remote, smaller sites affiliate with the SUNY NEXT to gain greater representation of rural Americans into clinical trials. Our success will shift paradigms for collaborative structuring of clinical trials and ultimately improv public health.
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海外基金