Cincinnati Neuroscience Clinical Trials Research Center (CinciNEXT)

辛辛那提神经科学临床试验研究中心 (CinciNEXT)

基本信息

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
项目类别：
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

项目摘要

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 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是辛辛那提独立的儿童医院医疗中心（CCHMC）与辛辛那提大学（UC）之间的独特合作，该公司的目的是继续成为Ninds资助的神经科学临床试验卓越网络的临床站点。拟议应用程序的目的是确保维持Cincinext站点在第一个支持周期为Neuronext网络进行的临床试验的出色质量所需的基础设施支持。 Cincinext的具体目标包括简化启动，增强招聘，最大化保留率并优化神经网络网络研究的研究行为。第二个目标是通过参与网络治理和网络委员会积极为神经网络的整体成功做出贡献。第三个目标是对新/初级临床研究人员进行持续的培训，以帮助他们发展技能和经验，以参与和/或领导Future Neuronext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Co-PI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），可用的患者鲁棒性广度和深度来实现这些目标。这两个机构都通过同意继续使用标准化的总试验协议，采用中央IRB审查，并提供额外的机构资金来支持两名全日制Cincinext研究协调员（一个专注于儿科和一个成年人专注），以表明他们对Neuronext的承诺。 Cincinext临床部位预计将继续为Neuronext试验提供出色的招聘，保留率和数据质量，从而为神经系统疾病提供预先治疗。 Cincinext网站是继续进行Ninds临床试验作为Neuronext网络的一部分的理想场所。