Clinical Centers for the NINDS NeuroNEXT(Network of Excellence in Neuroscience Clinical Trials) Consortium

NINDS NeuroNEXT（神经科学临床试验卓越网络）联盟的临床中心

• 批准号: 10744345
• 负责人: Michael Benatar
• 金额: $ 42.21万
• 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 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10744345
• 关键词: Acceleration; Adult; Aging; Agreement; Applications Grants; Award; Biological Markers; Black Populations; Black race; Caring; Catchment Area; Childhood; Clinic; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Network; Clinical and Translational Science Awards; Communities; Country; Data; Department chair; Development; Development Plans; Doctor of Philosophy; Education; Enrollment; Faculty; Fellowship; Florida; Funding; Goals; Grant; Growth; Hispanic; Hispanic Populations; Home; Hospitals; Individual; Industry; Infrastructure; Inpatients; Institution; Institutional Review Boards; Investments; Knowledge; Latino; Lead; Leadership; Mentors; Mentorship; Minority Recruitment; Mission; Modeling; Movement Disorders; Multi-Institutional Clinical Trial; Multicenter Studies; Multicenter Trials; National Institute of Neurological Disorders and Stroke; Neurodegenerative Disorders; Neurologic; Neurology; Neurosciences; Neurosciences Research; Nursing Research; Orphan; Outpatients; Patients; Pediatric Neurology; Play; Population Heterogeneity; Positioning Attribute; Process; Productivity; Protocols documentation; Rare Diseases; Recording of previous events; Research; Research Personnel; Research Training; Resources; Role; Science; Sensory; Services; Site; Societies; Training; Training and Education; Translational Research; United States National Institutes of Health; Universities; Visit; biomarker development; brain health; career; clinical center; clinical translation; community building; community engagement; design; ethnic diversity; experience; forest; medical schools; member; minority engagement; multi-site trial; nerve injury; nervous system disorder; neuroprotection; novel therapeutics; operation; organizational structure; participant enrollment; pediatric patients; product development; programs; racial diversity; recruit; research and development; skills; sound; success; training opportunity; translational research program; willingness; 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 willingness and desire to continue to serve as a clinical trial site in the NeuroNEXT consortium. The experience and expertise of the investigative team at the University of Miami (UM), the commitment, infrastructure and investment of the Department of Neurology and the Miller School of Medicine in clinical and translational research, and the ethnic and racial diversity (69% Hispanic, 17% 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大大促进。神经科学临床试验卓越网络（NeuroNEXT）旨在开展多个；科学合理的，可能有生物标记的，最有前途的治疗的探索性临床试验。该提案概述了迈阿密大学继续作为NeuroNEXT联盟临床试验基地的意愿和愿望。迈阿密大学（UM）调查团队的经验和专业知识，神经学系和米勒医学院在临床和转化研究方面的承诺，基础设施和投资，以及南佛罗里达社区的种族和种族多样性（69%的西班牙裔，17%的黑人），使我们能够为NINDS的使命做出贡献，减轻社会各阶层承担的神经系统疾病负担。除了作为NeuroNEXT联盟的高效和富有成效的成员外，我们还有能力和专业知识为在NeuroNEXT试验中招募西班牙裔和黑人做出重大贡献，这一人群在NINDS赞助的试验中一直代表性不足。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为更广泛的网络带来利益；并继续发展我们的临床转化人才队伍，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。研究战略的具体组成部分侧重于临床研究实施过程的效率、在招募西班牙裔人口时采用对文化敏感的方法、对新的临床研究人员进行教育和培训、承认研究协调员在临床试验过程中发挥的关键作用，并承诺向参与NINDS赞助的其他试验的研究人员提供专门知识和协助。