Clinical Coordinating Center Network of Excellence in Neuroscience Clinical Trial
神经科学临床试验卓越临床协调中心网络
基本信息
- 批准号:10213840
- 负责人:
- 金额:$ 240.23万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2011
- 资助国家:美国
- 起止时间:2011-09-30 至 2023-06-30
- 项目状态:已结题
- 来源:
- 关键词:AcademiaAdultApplications GrantsChildChildhoodClinicalClinical InvestigatorClinical ResearchClinical TrialsClinical Trials Data Monitoring CommitteesClinical Trials NetworkCollaborationsCommon Data ElementCommunicationCommunitiesCommunity NetworksConceptionsContractsDataData CollectionData Coordinating CenterDevelopmentDiseaseEducationEnsureFamilyFoundationsFundingGoalsGovernmentGrantIndividualIndustryInstitutional Review BoardsKnowledgeLeadLeadershipLogisticsMentorshipMethodologyMonitorMulti-Institutional Clinical TrialMulticenter TrialsNational Institute of Neurological Disorders and StrokeNeurologicNeurosciencesParticipantPatient RecruitmentsPatientsPopulationPopulation DecreasesPopulation HeterogeneityPrincipal InvestigatorPrivatizationProceduresProcessProtocols documentationPublicationsReportingResearchResearch DesignResearch PersonnelResourcesSafetyScheduleSiteSmall Business Innovation Research GrantStandardizationTestingTimeTrainingTraining ProgramsTraining and EducationTranslatingTranslationsUnited States National Institutes of HealthWorkclinical biomarkersclinical research sitecostdata managementearly phase clinical trialearly phase trialexperienceimprovedinnovationinvestigator trainingnervous system disordernovel therapeuticsparticipant retentionperformance siterecruitstroke clinical trialssuccesstrial design
项目摘要
The long-term objective of the Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT) initiative is to rapidly and efficiently translate advances in neuroscience into treatments for adults and children with neurological disorders through partnerships with government, academia, private foundations and industry. Recent discoveries in basic neuroscience have directly led to major breakthroughs in the understanding of disease processes in neurological disorders, many which impose an enormous burden on individuals, families and communities. Yet there are several organizational and logistical challenges to testing these new therapies in multicenter clinical trials, including inefficiencies in regulatory and institutional approvals, barriers to recruitment and retention of study participants and a dearth of individuals trained and prepared to be the leaders of multicenter clinical research trials, A central goal of NeuroNEXT is to facilitate, from initial conception through final analysis, high-quality early phase clinical trials and biomarker studies with clear go/no-go decisions by providing efficient methodological, organizational, statistical and logistical support. NeuroNEXT is comprised of 25 clinical sites, a Clinical Coordinating Center and a Data Coordinating Center. NeuroNEXT innovations include establishing a trial network that requires the use of a central institutional review board, a master contract process for all network- funded studies, centralized safety review of all studies by a single Data Safety Monitoring Board, broad sharing of Standard Operating Procedures and knowledge, state-of-the-art early development trial design approaches, and the use of the NINDS common data elements for data collection. Applicants who seek to use the network can be novice or experienced trialists, thereby greatly expanding the pool of experienced clinical investigators trained and prepared to lead multicenter trials. Nine studies involving partnerships with industry, foundations, academia and the government were funded in the first six years of the network. Specific Aim 1 is to work closely with the Data Coordinating Center to continue to support an open, collaborative network community that efficiently conducts high-quality clinical trials for neurological disorders. Specific Aim 2 is to greatly expand the pool of experienced clinical Investigators and research staff who are prepared to be leaders of multicenter clinical research trials by providing education, training, resources and professional mentorship. Specific Aim 3 is to continue to provide high-quality project management and regulatory coordination for all Network clinical trials.
神经科学临床试验卓越网络(NeuroNEXT)计划的长期目标是通过与政府,学术界,私人基金会和行业的合作伙伴关系,将神经科学的进步快速有效地转化为患有神经系统疾病的成人和儿童的治疗方法。基础神经科学的最新发现直接导致了对神经系统疾病过程的理解的重大突破,其中许多疾病给个人、家庭和社区带来了巨大负担。然而,在多中心临床试验中测试这些新疗法存在一些组织和后勤挑战,包括监管和机构批准的效率低下,招募和保留研究参与者的障碍以及缺乏经过培训和准备成为多中心临床研究试验领导者的个人。通过提供有效的方法学、组织、统计和后勤支持,为高质量的早期临床试验和生物标志物研究提供明确的进行/不进行决策。NeuroNEXT由25个临床研究中心、一个临床协调中心和一个数据协调中心组成。NeuroNEXT的创新包括建立一个试验网络,该网络需要使用中央机构审查委员会,所有网络资助的研究的主合同流程,由单个数据安全监测委员会对所有研究进行集中安全性审查,广泛共享标准操作规程和知识,最先进的早期开发试验设计方法,以及使用NINDS通用数据元素进行数据收集。寻求使用该网络的申请人可以是新手或经验丰富的试验者,从而大大扩大了经过培训并准备领导多中心试验的经验丰富的临床研究者的人数。在该网络的头六年里,资助了涉及与工业界、基金会、学术界和政府建立伙伴关系的九项研究。 具体目标1是与数据协调中心密切合作,继续支持一个开放、协作的网络社区,有效地开展高质量的神经系统疾病临床试验。 具体目标2是通过提供教育、培训、资源和专业指导,极大地扩大有经验的临床研究者和研究人员的队伍,他们准备成为多中心临床研究试验的领导者。 具体目标3是继续为所有网络临床试验提供高质量的项目管理和监管协调。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
MERIT E CUDKOWICZ其他文献
MERIT E CUDKOWICZ的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('MERIT E CUDKOWICZ', 18)}}的其他基金
Clinical Coordinating Center for the Network of Excellence in Neuroscience Clinical Trials (NEXT - CCC)
神经科学临床试验卓越网络临床协调中心 (NEXT - CCC)
- 批准号:
10741962 - 财政年份:2023
- 资助金额:
$ 240.23万 - 项目类别:
Clinical Coordinating Center Network of Excellence in Neuroscience Clinical Trial
神经科学临床试验卓越临床协调中心网络
- 批准号:
10468050 - 财政年份:2011
- 资助金额:
$ 240.23万 - 项目类别:
Clinical Coordinating Center Network of Excellence in Neuroscience Clinical Trial
神经科学临床试验卓越临床协调中心网络
- 批准号:
8539105 - 财政年份:2011
- 资助金额:
$ 240.23万 - 项目类别:
Clinical Coordinating Center Network of Excellence in Neuroscience Clinical Trial
神经科学临床试验卓越临床协调中心网络
- 批准号:
8338822 - 财政年份:2011
- 资助金额:
$ 240.23万 - 项目类别:
Clinical Coordinating Center Network of Excellence in Neuroscience Clinical Trial
神经科学临床试验卓越临床协调中心网络
- 批准号:
8885926 - 财政年份:2011
- 资助金额:
$ 240.23万 - 项目类别:
Clinical Coordinating Center Network of Excellence in Neuroscience Clinical Trial
神经科学临床试验卓越临床协调中心网络
- 批准号:
9069323 - 财政年份:2011
- 资助金额:
$ 240.23万 - 项目类别:
Clinical Coordinating Center Network of Excellence in Neuroscience Clinical Trial
神经科学临床试验卓越临床协调中心网络
- 批准号:
10015348 - 财政年份:2011
- 资助金额:
$ 240.23万 - 项目类别:
Clinical Coordinating Center Network of Excellence in Neuroscience Clinical Trial
神经科学临床试验卓越临床协调中心网络
- 批准号:
9308007 - 财政年份:2011
- 资助金额:
$ 240.23万 - 项目类别:
Clinical Coordinating Center Network of Excellence in Neuroscience Clinical Trial
神经科学临床试验卓越临床协调中心网络
- 批准号:
8550171 - 财政年份:2011
- 资助金额:
$ 240.23万 - 项目类别:
Clinical Coordinating Center Network of Excellence in Neuroscience Clinical Trial
神经科学临床试验卓越临床协调中心网络
- 批准号:
8239805 - 财政年份:2011
- 资助金额:
$ 240.23万 - 项目类别:
相似海外基金
Co-designing a lifestyle, stop-vaping intervention for ex-smoking, adult vapers (CLOVER study)
为戒烟的成年电子烟使用者共同设计生活方式、戒烟干预措施(CLOVER 研究)
- 批准号:
MR/Z503605/1 - 财政年份:2024
- 资助金额:
$ 240.23万 - 项目类别:
Research Grant
Early Life Antecedents Predicting Adult Daily Affective Reactivity to Stress
早期生活经历预测成人对压力的日常情感反应
- 批准号:
2336167 - 财政年份:2024
- 资助金额:
$ 240.23万 - 项目类别:
Standard Grant
RAPID: Affective Mechanisms of Adjustment in Diverse Emerging Adult Student Communities Before, During, and Beyond the COVID-19 Pandemic
RAPID:COVID-19 大流行之前、期间和之后不同新兴成人学生社区的情感调整机制
- 批准号:
2402691 - 财政年份:2024
- 资助金额:
$ 240.23万 - 项目类别:
Standard Grant
Migrant Youth and the Sociolegal Construction of Child and Adult Categories
流动青年与儿童和成人类别的社会法律建构
- 批准号:
2341428 - 财政年份:2024
- 资助金额:
$ 240.23万 - 项目类别:
Standard Grant
Elucidation of Adult Newt Cells Regulating the ZRS enhancer during Limb Regeneration
阐明成体蝾螈细胞在肢体再生过程中调节 ZRS 增强子
- 批准号:
24K12150 - 财政年份:2024
- 资助金额:
$ 240.23万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Understanding how platelets mediate new neuron formation in the adult brain
了解血小板如何介导成人大脑中新神经元的形成
- 批准号:
DE240100561 - 财政年份:2024
- 资助金额:
$ 240.23万 - 项目类别:
Discovery Early Career Researcher Award
RUI: Evaluation of Neurotrophic-Like properties of Spaetzle-Toll Signaling in the Developing and Adult Cricket CNS
RUI:评估发育中和成年蟋蟀中枢神经系统中 Spaetzle-Toll 信号传导的神经营养样特性
- 批准号:
2230829 - 财政年份:2023
- 资助金额:
$ 240.23万 - 项目类别:
Standard Grant
Usefulness of a question prompt sheet for onco-fertility in adolescent and young adult patients under 25 years old.
问题提示表对于 25 岁以下青少年和年轻成年患者的肿瘤生育力的有用性。
- 批准号:
23K09542 - 财政年份:2023
- 资助金额:
$ 240.23万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Identification of new specific molecules associated with right ventricular dysfunction in adult patients with congenital heart disease
鉴定与成年先天性心脏病患者右心室功能障碍相关的新特异性分子
- 批准号:
23K07552 - 财政年份:2023
- 资助金额:
$ 240.23万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Issue identifications and model developments in transitional care for patients with adult congenital heart disease.
成人先天性心脏病患者过渡护理的问题识别和模型开发。
- 批准号:
23K07559 - 财政年份:2023
- 资助金额:
$ 240.23万 - 项目类别:
Grant-in-Aid for Scientific Research (C)