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: 9293406
• 负责人: TRACY A GLAUSER
• 金额: $ 31.15万
• 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 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9293406
• 关键词: Adult; Affect; Agreement; Biological Markers; Budgets; Caring; Childhood; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Community Outreach; Complement; Complex; Conduct Clinical Trials; Contracts; Country; Development; Disease; Electronic Mail; Enrollment; Foundations; Funding; Future; Goals; Health; Institution; International; Intervention Trial; Lead; Leadership; Letters; Location; Mediation; Medical center; Modeling; National Institute of Neurological Disorders and Stroke; Neurologic; Neurosciences; Outcome; Patient Recruitments; Patients; Pediatric Hospitals; Persons; Phase; Population; Preparation; Protocols documentation; Rare Diseases; Recruitment Activity; Research; Research Design; Research Infrastructure; Research Personnel; Resources; Role; Site; Standardization; Time; Time Study; Training; United States National Institutes of Health; Universities; 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）和辛辛那提大学（UC）之间的独特合作，旨在成为NIDS资助的神经科学临床试验卓越网络（NEXT）网络中的临床研究中心。拟议申请的目的是获得基础设施支持，以促进在CinciNEXT研究中心为NEXT网络进行的临床试验的实施和优化质量。CinciNEXT的具体目标是简化启动，加强招募，最大限度地保留和优化NEXT网络研究的研究实施。另一个目标是通过参与网络治理、工作组（例如专注于规划和实施协议）和网络活动，积极为NEXT网络的整体成功做出贡献。第三个目标是对新的/初级临床研究者/研究协调员进行持续培训，以帮助他们发展参与和/或领导未来NEXT和其他NINDS试验的技能和经验。这些目标将通过我们经验丰富的CinciNEXT领导团队（两名合作者和两名全职研究协调员），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组合来实现。这两家机构都同意使用标准化的主试验协议，采用一级集中IRB审查，并提供额外的机构资金支持两名全职CinciNEXT研究协调员（一名以儿科为重点，一名以成人为重点），从而表明了他们对NEXT网络的承诺。CinciNEXT临床研究中心预计将为NEXT Network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。CinciNEXT计划成为NINDS网络的关键合作伙伴，该网络将提供强大，标准化和可访问的基础设施，以促进影响成人和儿科人群的神经系统疾病协议的快速开发和实施。