Cincinnati Neuroscience Clinical Trials Research Center (CinciNEXT)

描述(由申请人提供)：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NLNDS资助的神经科学临床试验卓越网络(NEXT)网络中的一个临床网站。拟议应用程序的目标是获得基础设施支持，以促进在CincNEXT网站为Next Network进行的临床试验的实施并优化其质量。CincNEXT的具体目标是简化启动、加强招聘、最大限度地留住人才并优化Next Network Study的学习实施。另一个目标是通过参与网络治理、工作组(例如，侧重于规划和实施协议)和网络活动，积极促进下一个网络的全面成功。第三个目标是实施对新的/初级临床研究人员/研究协调员的持续培训，以帮助他们发展参与和/或领导未来的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CincNEXT领导团队(两名联合Pls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共同努力来实现。这两个机构都通过同意使用标准化的总试验协议，采用一级集中IRB审查，并提供额外的机构资金来支持两名全职CincNEXT研究协调员(一名专注于儿科，一名专注于成人)，以表明他们对Next Network的承诺。CincNEXT临床网站预计将为Next Network试验提供出色的招募、保留和质量，从而推动神经疾病的治疗。CincNEXT建议成为NINDS网络中的关键合作伙伴，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童人口的神经疾病方案的快速开发和实施。

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.