Cincinnati Neuroscience Clinical Trials Research Center (CinciNEXT)

辛辛那提神经科学临床试验研究中心 (CinciNEXT)

• 批准号: 8869050
• 负责人: TRACY A GLAUSER
• 金额: $ 25.55万
• 依托单位: UNIVERSITY OF CINCINNATI
• 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 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8869050
• 关键词: Academic Medical Centers; Adult; Affect; Agreement; Biological Markers; Budgets; Caring; Childhood; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Communication; Community Outreach; Complement; Complex; Conduct Clinical Trials; Contracts; Country; Development; Disease; Electronics; Enrollment; Foundations; Funding; Future; Goals; Health; Institution; Intervention Trial; Lead; Leadership; Letters; Location; Mediation; Modeling; National Institute of Neurological Disorders and Stroke; Neurologic; Neurosciences; Outcome; Patient Recruitments; Patients; Pediatric Hospitals; Persons; Phase; Population; Preparation; Protocols documentation; Research; Research Design; Research Infrastructure; Research Personnel; Resources; Role; Site; Time; Training; United States National Institutes of Health; clinical practice; clinical research site; experience; improved; nervous system disorder; patient population; research study; skills; success; willingness; working group

DESCRIPTION (provided by applicant): 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 be a clinical site in the NlNDS-funded Network for Excellence in Neuroscience Clinical Trials (NEXT) network. The objective of the proposed application is to obtain infrastructural support to facilitate the implementation and optimize the quality of clinica trials conducted at the CinciNEXT site for the NEXT Network. Specific goals of CinciNEXT are to streamline startup, enhance recruitment, maximize retention and optimize study conduct of NEXT Network studies. Another goal is to actively contribute to the overall success of the NEXT network by participating in network governance, working groups (e.g. focused on planning and implementation of protocols), and network activities. The third goal is to implement ongoing training of new/junior clinical investigators/study coordinators to help them develop skills and experience to participate and/or lead future NEXT and other NINDS trials. These goals will be achieved by the combination of our experienced CinciNEXT leadership team (two co-Pls and two full-time research study coordinators), 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 NEXT Network by agreeing to use a standardized Master Trial Agreement, employ a Tier 1 level of centralized IRB review, and provide additional institutional funds to support two full-time CinciNEXT study coordinators (one pediatric-focused and one adult-focused). The CinciNEXT clinical site anticipates providing outstanding recruitment, retention and quality for NEXT Network trials, and thereby advancing treatments for neurological disorders. CinciNEXT proposes to be a key partner in this NINDS network that will provide a robust, standardized, and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and pediatric populations.

描述（由申请人提供）：Cincinext是独立的辛辛那提儿童医院医疗中心（CCHMC）与辛辛那提大学（UC）（UC）之间的独特合作，其目的是成为NLNDS资助的Neuroscience Clinical Clinical clialical clialical triale triale（下一个）网络（下一个）网络（下一个）网络的临床网站。拟议应用程序的目的是获得基础设施支持，以促进实施并优化下一个网络在Cincinext站点进行的临床试验质量。 Cincinext的具体目标是简化启动，增强招聘，最大化保留率并优化下一个网络研究的研究。另一个目标是通过参与网络治理，工作组（例如，专注于计划和实施协议）和网络活动来积极为下一个网络的整体成功做出贡献。第三个目标是对新/初级临床研究人员/研究协调员进行正在进行的培训，以帮助他们发展技能和经验，以参与和/或带领未来的Next和其他NINDS试验。这些目标将通过我们经验丰富的Cincinext领导团队（两个共同PLS和两个全日制研究协调员），热情的研究合作者，现有杰出的研究基础设施（包括CTSA），可用于参与试验的患者的鲁棒性广度和深度以及两个支持性研究管理局的结合来实现这些目标。这两个机构都通过同意使用标准化的大师试验协议，采用1级集中式IRB审查，并提供额外的机构资金来支持两个全职Cincinext研究协调员（一名以儿科专注于儿科和以成人为中心的成人）来支持他们对下一个网络的承诺。 Cincinext临床网站预计将为下一次网络试验提供出色的招聘，保留率和质量，从而为神经系统疾病提供治疗。 Cincinext提议成为这个NINDS网络中的关键合作伙伴，该网络将提供强大，标准化且可访问的基础设施，以促进影响成人和儿科人群的神经系统疾病的快速发展和实施。