Clinical Research Sites for the Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT sites) (U24)

神经科学临床试验卓越网络的临床研究站点（NeuroNEXT 站点）(U24)

• 批准号: 10163276
• 负责人: CLAUDIA A CHIRIBOGA
• 金额: $ 30.68万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-15 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10163276
• 关键词: Academic Medical Centers; Address; Adult; Advisory Committees; Advocate; All of Us Research Program; Alzheimer' s Disease; Ambulatory Care; Award; Binding Sites; Bioinformatics; Biological Markers; Caring; Childhood; Clinical; Clinical Research; Clinical Trials; Collaborations; Communities; Conduct Clinical Trials; County; Data; Development; Disease; Doctor of Medicine; Enrollment; Epidemiology; Epilepsy; Faculty; Family; Fellowship; Foundations; Funding; Future; Gilles de la Tourette syndrome; Goals; Health Personnel; Hospitals; Individual; Industry; Informatics; Information Dissemination; Infrastructure; Institution; Institutional Review Boards; Joints; Leadership; Learning; Link; Longevity; Medical center; Mentors; Mentorship; Methodist Church; Methodology; Minority Recruitment; Monitor; Multiple Sclerosis; National Institute of Neurological Disorders and Stroke; Neuroepidemiology; Neurologist; Neurosciences; New York; Parkinson Disease; Participant; Patient Care; Patients; Pediatric Neurology; Peripheral Nervous System Diseases; Phase; Phase II Clinical Trials; Population Heterogeneity; Presbyterian Church; Problem Solving; Rare Diseases; Recording of previous events; Research; Research Personnel; Research Training; Resources; Scientific Advances and Accomplishments; Side; Site; Stroke; StrokeNet trials; Time; Training; United States National Institutes of Health; Universities; base; bilingualism; biobank; career development; clinical biomarkers; clinical candidate; clinical center; clinical research site; design; ethnic diversity; experience; improved; innovation; medical schools; meetings; nervous system disorder; neurogenetics; neurosurgery; new technology; next generation; patient population; personalized medicine; precision medicine; programs; recruit; success; synergism; telehealth; tool; training opportunity; validation studies; working group

The Columbia University Medical Center-Weill Cornell Medical Center NNEXT site has increased the efficiency of clinical research sponsored by NINDS, by creating a shared infrastructure that has benefited from existing resources, including two CTSAs, to conduct seven Phase II exploratory trials and one biomarker study. Four studies are completed, and four are underway. The joint NNEXT site has been led by PIs Karen Marder M.D. MPH and Claudia Chiriboga M.D. MPH at CUMC, and now, emblematic of the increased synergy between CUMC and WCMC, Claire Henchcliffe M.D. DPhil at WCMC will join as PI. The two neuroscience centers have a long history of collaboration in research; their respective hospitals are combined (New York Presbyterian Hospital), and they both have CTSAs linked in a regional consortium, the NYCON. Since 2011 our institutions have strengthened their relationship through an emphasis on Precision Medicine’s “All of Us” program. Our aims are 1) To build upon the success of our joint neuroscience CUMC-WCMC clinical trials site, capable of conducting the planned five to ten NNEXT trials, by drawing on our extensive expertise in adult and pediatric neurology, neurosurgery, and basic neuroscience. We have developed a recruitment strategy for rare and more common neurological diseases, making use of our respective communities, ambulatory care networks, and advanced bioinformatics. Our recruitment efforts will dovetail with our three-pronged goal to educate families through bilingual (English and Spanish) disease-specific programs. We will be guided by a Recruitment Retention Core composed of individuals with expertise (minority recruitment, epidemiology) providing practical real-time problem-solving to NEXT trialists. 2) To leverage resources from the CTSA, Office of Clinical Trials, IRB, and the Office of Research Compliance and Training, at each center to efficiently identify and expeditiously recruit ethnically diverse participants who are followed to trial completion. 3) To participate in, and contribute to, the NNEXT network by developing our own clinical trials. We have identified a team of co-investigators at both sites who have experience in NIH, industry and foundation supported clinical trials, have demonstrated partnership with foundations, and have a commitment to mentorship. A NEXT Advisory Committee including senior leadership will provide guidance on both current and future projects. 4) To train the next generation of clinical and basic neuroscientists to become independent investigators, able to design and conduct clinical trials, and benefiting from new technologies and trial methodologies. To this end, we will organize a multifaceted program for faculty career-development. 5) To improve dissemination of information to patients, families, and disease-specific advocates about scientific advances and the importance of clinical trials in our community, using educationally and culturally appropriate tools, and innovations including telehealth to reach a broader public.

哥伦比亚大学医学中心 - 康奈尔医学中心Nnext网站通过创建一个共享的基础设施来提高了由NINDS赞助的临床研究效率，该基础设施受益于现有资源，包括两个CTSA，以进行七项II期探索性试验和一项生物标志物研究。四项研究完成了，正在进行四项研究。联合NNEXT位点由PIS Karen Marder M.D. MPH和CUMC的Claudia Chiriboga M.D. MPH领导，现在象征CUMC和WCMC之间的协同作用，Claire Henchcliffe M.D. Dphil在WCMC的DPHIL将加入PI。两个神经科学中心在研究方面的合作历史悠久。他们各自的医院合并（纽约长老会医院），他们都在一个区域财团NYCON中有CTSA。自2011年以来，我们的机构通过强调精密医学的“我们所有人”计划来加强他们的关系。我们的目标是1）建立在我们联合神经科学CUMC-WCMC临床试验站点的成功基础上，能够通过利用我们在成人和儿科神经病学，神经外科手术和基本神经科学方面的广泛专业知识来进行计划的五到十个NNEXT试验。我们已经制定了一种针对罕见，更常见的神经系统疾病的招聘策略，利用我们的相对社区，门诊护理网络和先进的生物信息学。我们的招聘工作将与我们三管齐下的目标相吻合，以通过双语（英语和西班牙语）特定的计划来教育家庭。我们将受到由具有专业知识的个人（少数族裔，流行病学）组成的招聘保留核心，为下一个试验者提供实时解决的实时问题。 2）在每个中心利用CTSA的资源，IRB临床试验办公室以及研究合规性和培训办公室，以有效地识别并迅速招募了遵循试验完成的种族多样化的参与者。 3）通过开发自己的临床试验，参与Nnext网络并为NNEXT网络做出贡献。我们已经确定了在NIH，行业和基金会支持临床试验经验的两个网站上的共同投资者团队，已经证明了与基金会的伙伴关系，并且对心态有承诺。包括高级领导在内的下一个咨询委员会将为当前和将来的项目提供指导。 4）培训下一代临床和基本神经科学家，成为独立研究者，能够设计和进行临床试验，并从新技术和试验方法中受益。为此，我们将组织一个多方面的教师职业发展计划。 5）通过使用教育和文化上适当的工具以及包括远程医疗在内的创新来提高有关科学进步以及临床试验在我们社区中临床试验的重要性的信息，以及在我们社区中临床试验的重要性。