University of Miami NeuroNEXT Trial Site

迈阿密大学 NeuroNEXT 试验网站

• 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
• 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

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.

神经系统疾病患者的新疗法的开发，这关键取决于临床试验的效率，可能会大大促进临床试验财团。神经科学临床试验卓越网络（NeuroNEXT）旨在对最有前途的疗法进行多项;科学合理的，可能的生物标志物知情的探索性临床试验。该提案概述了迈阿密大学与内穆尔儿童医院合作开展儿科研究的申请，该申请将作为NeuroNEXT联盟的临床试验地点。迈阿密大学（UM）和内穆尔大学调查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，以及种族和种族多样性（66%的西班牙裔，19%的黑人）的南佛罗里达社区，这使我们能够为NINDS的使命做出贡献，以减轻社会各阶层所承受的神经疾病负担。除了作为NeuroNEXT联盟的高效和富有成效的成员外，我们有能力和专业知识为NeuroNEXT试验中的西班牙裔和黑人的招募做出重大贡献，这一人口统计在NINDS申办的试验中历来代表性不足。我们的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为更广泛的网络带来利益;并继续发展我们的临床翻译团队，为年轻的研究人员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招募西班牙裔人群，教育和培训新的临床研究者，承认研究协调员在临床试验过程中发挥的关键作用，并承诺为参与其他NINDS申办试验的研究者提供专业知识和帮助。