University of Miami NeuroNEXT Trial Site

迈阿密大学 NeuroNEXT 试验网站

基本信息

批准号：
10201771
负责人：
Michael Benatar
金额：
$ 26.11万
依托单位：
UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
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/10201771
关键词：
Admission activity Adult Aging Agreement Ambulatory Care Facilities Applications Grants Area Award Biological Markers Caring Catchment Area Childhood Clinic Clinical Clinical Investigator Clinical Nursing Research Clinical Research Clinical Trials Clinical Trials Network Clinical and Translational Science Awards Communities Consultations Country Data Department chair Development Doctor of Philosophy Engineering Enrollment Faculty Florida Funding Goals Grant Growth Hispanics Home Hospitals Industry Infrastructure Inpatients Institution Institutional Review Boards Investigation Investments Knowledge Latino Lead Leadership Mentorship Minority Recruitment Mission Modeling Monitor Multi-Institutional Clinical Trial Multicenter Studies Multicenter Trials National Institute of Neurological Disorders and Stroke Neurodegenerative Disorders Neurologic Neurology Neurosciences Neurosciences Research Orphan Outpatients Patients Pediatric Hospitals Play Population Population Heterogeneity Positioning Attribute Principal Investigator Process Protocols documentation Rare Diseases Recording of previous events Research Research Personnel Resources Role Science Sensory Services Site Societies Training Training and Education Translational Research United States National Institutes of Health Universities Visit base biomarker development biomarker validation brain health career clinical center clinical trial implementation community engagement design ethnic diversity experience medical schools medical specialties meetings member nerve injury nervous system disorder neuroprotection novel therapeutics operation organizational structure pediatric department pediatric patients product development programs racial diversity recruit sound success training opportunity translational research program working group

项目摘要

The development of new therapeutics for patients with neurological disorders, which critically hinges on the efficiency of clinical trials, may be greatly facilitated by clinical trials consortia. The Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT) aims to conduct multiple; scientifically sound, possibly biomarker informed, exploratory clinical trials of the most promising therapies. This proposal outlines the University of Miami's application to serve as a clinical trial site in the NeuroNEXT consortium, in partnership with Nemours Children's Hospital for pediatric studies. The experience and expertise of the investigative team at the University of Miami (UM) and Nemours, the commitment, infrastructure and investment of the Department of Neurology and the School of Medicine in clinical and translational research, and the ethnic and racial diversity (66% Hispanic, 19% Black) of the south Florida community, uniquely position us to contribute to the mission of NINDS to reduce the burden of neurological disease that is borne by every segment of society. In addition to serving as an efficient and productive member of the NeuroNEXT consortium, we have the capacity and expertise to make a significant contribution to the enrollment of Hispanics and Blacks in NeuroNEXT trials, a demographic that has historically been underrepresented in NINDS sponsored trials. The specific goals of our NeuroNEXT team are to continue service as an effective site in the NeuroNEXT network, leveraging our unique strengths and expertise for the benefit of the broader network; and to continue development our clinical-translational workforce, providing young investigators and research staff with educational, training and career growth opportunities. Specific components of the research strategy focus on the efficiency of the process of clinical research implementation, the use of a culturally sensitive approaches to recruitment of the Hispanic population, education and training of new clinical investigators, recognition of the pivotal role that research coordinators play in the clinical trials process and a commitment to provide expertise and assistance to investigators engaged in other NINDS sponsored trials.

神经系统疾病患者新疗法的开发关键取决于临床试验的效率，临床试验联盟可能会极大地促进这一过程。神经科学临床试验卓越网络 (NeuroNEXT) 旨在开展多项；对最有希望的疗法进行科学合理、可能具有生物标志物信息的探索性临床试验。该提案概述了迈阿密大学与内穆尔儿童医院合作作为 NeuroNEXT 联盟临床试验中心的申请。迈阿密大学 (UM) 和内穆尔研究团队的经验和专业知识，神经病学系和医学院在临床和转化研究方面的承诺、基础设施和投资，以及民族和种族多样性（66%）佛罗里达州南部社区的西班牙裔（19% 是黑人）使我们处于独特的地位，可以为 NINDS 的使命做出贡献，即减轻社会各阶层所承受的神经系统疾病的负担。除了作为 NeuroNEXT 联盟高效且富有成效的成员之外，我们还有能力和专业知识为 NeuroNEXT 试验中西班牙裔和黑人的注册做出重大贡献，这一人群历来在 NINDS 赞助的试验中代表性不足。我们 NeuroNEXT 团队的具体目标是继续作为 NeuroNEXT 网络中的有效站点提供服务，利用我们独特的优势和专业知识来造福更广泛的网络；继续发展我们的临床翻译队伍，为年轻的研究者和研究人员提供教育、培训和职业发展机会。研究策略的具体组成部分侧重于临床研究实施过程的效率、使用文化敏感的方法来招募西班牙裔人口、新临床研究人员的教育和培训、认识到研究协调员在临床研究中发挥的关键作用。临床试验过程以及为参与其他 NINDS 赞助试验的研究人员提供专业知识和帮助的承诺。