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: 10166966
• 负责人: TRACY A GLAUSER
• 金额: $ 30.45万
• 依托单位: UNIVERSITY OF CINCINNATI
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10166966
• 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; Conduct Clinical Trials; Country; Data; Development; Education; Enrollment; Foundations; Funding; Future; Generations; Goals; Health; Infrastructure; Institution; Institutional Review Boards; International; Intervention Trial; Lead; Leadership; Letters; Location; Medical center; Modeling; National Institute of Neurological Disorders and Stroke; Network Infrastructure; Neurology; Neurosciences; Participant; Patient Recruitments; Patients; Pediatric Hospitals; Phase; Phase III Clinical Trials; Population; Preparation; Protocols documentation; Randomized; Research; Research Design; Research Infrastructure; Role; Secure; Site; Standardization; Time; Time Study; Training; United States National Institutes of Health; Universities; clinical biomarkers; clinical center; clinical research site; data quality; experience; implementation facilitation; improved; nervous system disorder; patient population; programs; recruit; research study; skills; success; web site; willingness

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 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 NeuroNEXT Network during the first cycle of support. Specific goals of CinciNEXT include to streamline startup, 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 and network committees. The third goal is to implement ongoing training of new/junior clinical investigators 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 two fulltime 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 NeuroNEXT by agreeing to continue to use a standardized Master Trial Agreement, employ central 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 continuing to provide outstanding recruitment, retention and data quality for NeuroNEXT trials, and thereby advance treatments for neurological disorders. The CinciNEXT site is an ideal location to continue to conduct NINDS clinical trials as part of the NeuroNEXT network.

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，旨在继续成为NINDS资助的神经科学临床试验卓越网络（NeuroNEXT）网络中的临床站点。拟议申请的目的是确保所需的基础设施支持，以保持CinciNEXT研究中心在第一个支持周期内为NeuroNEXT网络进行的临床试验的出色质量。CinciNEXT的具体目标包括简化启动，加强招募，最大限度地保留和优化NeuroNEXT网络研究的研究进行。第二个目标是通过参与网络治理和网络委员会，积极为NeuroNEXT网络的整体成功做出贡献。第三个目标是对新的/初级临床研究者进行持续培训，帮助他们发展参与和/或领导未来NeuroNEXT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（两名共同PI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。这两家机构都已通过同意继续使用标准化的主试验协议，采用中心IRB审查，并提供额外的机构资金来支持两名全职CinciNEXT研究协调员（一名专注于儿科，一名专注于成人），表明了他们对NeuroNEXT的承诺。CinciNEXT临床研究中心预计将继续为NeuroNEXT试验提供出色的招募、保留和数据质量，从而推进神经系统疾病的治疗。CinciNEXT网站是继续进行NINDS临床试验的理想场所，作为NeuroNEXT网络的一部分。