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

Clinical Research Sites for the Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT sites)
神经科学临床试验卓越网络的临床研究网站(NeuroNEXT 网站)
批准号:
10744306
负责人:
TRACY A GLAUSER
金额:
$46.02万
依托单位:
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:
未结题
起止时间:
2018-07-01 至 2028-06-30

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中文摘要
翻译
辛辛那提ext是独立的辛辛那提儿童医院医学中心(CCHMC)和辛辛那提大学(UC)之间的独特合作,旨在继续成为ninds资助的神经科学临床试验卓越网络(NeuroNEXT)网络中富有成效的临床站点。拟议申请的目的是确保在第一和第二周期的支持期间,维持辛辛纳特中心为NEXT网络进行的临床试验的卓越质量所需的基础设施支持。辛辛那提的具体目标是促进实施,加强招聘,最大限度地保留,并优化NeuroNEXT网络研究的研究行为。第二个目标是通过参与网络治理、网络委员会和网络活动,积极为NeuroNEXT网络的整体成功做出贡献。第三个目标是实施一个新的/初级研究员职业发展计划,帮助他们发展技能和经验,以参与和/或领导未来的NeuroNEXT和其他NINDS试验。这些目标将通过我们经验丰富的cincinnati领导团队(两名联合pi和一名全职研究协调员,拥有超过9年的NeuroNEXT工作经验),热情的研究合作者,现有的优秀研究基础设施(包括CTSA),可参与试验的患者的强大广度和深度,以及两个支持性研究管理部门的结合来实现。两家机构都表明了他们对NeuroNEXT网络的承诺,同意继续使用标准化的主试验协议,并采用一级集中式IRB审查。辛辛那提临床站点预计将继续为NeuroNEXT网络试验提供出色的招募、保留和质量,从而推进神经系统疾病的治疗。辛辛那提提议成为该NINDS网络的主要合作伙伴,该网络提供了一个强大的、标准化的和可访问的基础设施,以促进影响成人和儿童人群的神经系统疾病方案的快速开发和实施。
英文摘要
CinciNEXT is a unique collaboration between the free-standing Cincinnati Children’s Hospital Medical Center (CCHMC) and the University of Cincinnati (UC) that aims to continue to be a productive clinical site in the NINDS-funded Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) network. The objective of the proposed application is to secure the infrastructural support needed to maintain the outstanding quality of clinical trials that the CinciNEXT site has conducted for the NEXT Network during the first and second cycles of support. Specific goals of CinciNEXT are to facilitate the implementation, enhance recruitment, maximize retention, and optimize study conduct of NeuroNEXT network studies. A second goal is to actively contribute to the overall success of the NeuroNEXT network by participating in network governance, network committees, and network activities. The third goal is to implement a new/junior investigator career advancement program to help them develop skills and experience to participate and/or lead future NeuroNEXT and other NINDS trials. These goals will be achieved by the combination of our experienced CinciNEXT leadership team (two co-PIs and one fulltime research study coordinator with over 9 years of NeuroNEXT experience working together), enthusiastic research collaborators, existing outstanding research infrastructure (including a CTSA), robust breadth and depth of patients available to participate in trials, and two supportive research administrations. Both institutions have shown their commitment to the NeuroNEXT Network by agreeing to continue to use a standardized Master Trial Agreement and employ a Tier 1 level of centralized IRB review. The CinciNEXT clinical site anticipates continuing to provide outstanding recruitment, retention, and quality for NeuroNEXT network trials, and thereby advancing treatments for neurological disorders. CinciNEXT proposes to be a key partner in this NINDS network that has provided a robust, standardized, and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and pediatric populations.
期刊论文(5)
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会议论文
DOI: 10.1097/md.0000000000028645
发表时间: 2022-01-21
期刊: Medicine
影响因子: 1.6
作者: [Sawyer RP, Hill EJ, Yokoyama J, Medvedovic M, Ren Y, Zhang X, Choubey D, Shatz RS, Miller B, Woo D]
通讯作者: Woo D
DOI: 10.1111/epi.16984
发表时间: 2021-09
期刊: Epilepsia
影响因子: 5.6
作者: []
通讯作者:
DOI: 10.1016/j.conctc.2021.100821
发表时间: 2021-09
期刊: Contemporary clinical trials communications
影响因子: 1.5
作者: [Lowenhaupt S, Molloy A]
通讯作者: Molloy A
Clinical Pharmacology K12 Training Program
Cincinnati Neuroscience Clinical Trials Research Center (CinciNEXT)
  • 批准号:
    10166966
  • 项目类别:
  • 资助金额:
    $30.45万
  • 财政年份:
    2018
  • 负责人:
    TRACY A GLAUSER
  • 依托单位:
Cincinnati Neuroscience Clinical Trials Research Center (CinciNEXT)
  • 批准号:
    10593621
  • 项目类别:
  • 资助金额:
    $29.95万
  • 财政年份:
    2018
  • 负责人:
    TRACY A GLAUSER
  • 依托单位:
Cincinnati Neuroscience Clinical Trials Research Center (CinciNEXT)
  • 批准号:
    8869050
  • 项目类别:
  • 资助金额:
    $25.55万
  • 财政年份:
    2011
  • 负责人:
    TRACY A GLAUSER
  • 依托单位:
海外基金