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: 10593610
• 负责人: CLAUDIA A CHIRIBOGA
• 金额: $ 30.11万
• 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 2023-06-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10593610
• 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-威尔康奈尔医学中心NNEXT站点通过创建共享基础设施来提高由NINDS赞助的临床研究的效率，该基础设施受益于现有资源，包括两个CTSAs，以进行七项II期探索性试验和一项生物标志物研究。四项研究已经完成，四项正在进行中。NNEXT联合项目由中国中医药大学的Karen Marder医学博士和Claudia Chiriboga医学博士领导，现在，作为中国中医药大学和WCMC之间日益增强的协同作用的象征，WCMC的Claire Henchcliffe医学博士将加入作为PI。这两个神经科学中心在研究方面有着悠久的合作历史；它们各自的医院是合并的（纽约长老会医院），而且它们都有与地区性联盟NYCON联系在一起的ctsa。自2011年以来，我们的机构通过强调精准医疗的“我们所有人”计划加强了他们的关系。我们的目标是1)利用我们在成人和儿童神经病学、神经外科和基础神经科学方面的广泛专业知识，在我们联合神经科学CUMC-WCMC临床试验基地的成功基础上，能够进行计划中的5到10个NNEXT试验。我们利用各自的社区、门诊护理网络和先进的生物信息学，制定了针对罕见和更常见的神经系统疾病的招募策略。我们的招聘工作将与我们的三管齐下的目标相吻合，即通过双语（英语和西班牙语）疾病专门课程对家庭进行教育。我们将由具有专业知识（少数民族招募，流行病学）的个人组成的招聘保留核心指导，为NEXT试验人员提供实际的实时问题解决方案。2)利用来自CTSA、临床试验办公室、IRB和研究合规与培训办公室的资源，在每个中心有效地识别和迅速招募不同种族的参与者，并跟踪他们完成试验。3)通过开发我们自己的临床试验，参与NNEXT网络并为其做出贡献。我们已经在两个地点确定了一个共同研究小组，他们在NIH、行业和基金会支持的临床试验中都有经验，已经证明了与基金会的合作伙伴关系，并承诺提供指导。包括高级领导在内的NEXT咨询委员会将为当前和未来的项目提供指导。4)培养下一代临床和基础神经科学家成为独立的研究者，能够设计和开展临床试验，并受益于新技术和试验方法。为此，我们将组织一个多方面的教师职业发展计划。5)利用教育和文化上适当的工具以及包括远程保健在内的创新，向患者、家属和特定疾病倡导者传播有关科学进展和临床试验在我们社区中的重要性的信息。

项目成果

Selected health and lifestyle factors, cytosine-adenine-guanine status, and phenoconversion in Huntington's disease.

• DOI: 10.1002/mds.27239
• 发表时间: 2018-03
• 期刊: Movement disorders : official journal of the Movement Disorder Society
• 作者: Tanner C;Marder K;Eberly S;Biglan K;Oakes D;Shoulson I;Huntington Study Group Prospective Huntington At-Risk Observational Study Investigators
• 通讯作者: Huntington Study Group Prospective Huntington At-Risk Observational Study Investigators

ROBUST MIXED EFFECTS MODEL FOR CLUSTERED FAILURE TIME DATA: APPLICATION TO HUNTINGTON'S DISEASE EVENT MEASURES.

集群故障时间数据的鲁棒混合效应模型：应用于亨廷顿病事件测量。

• DOI: 10.1214/17-aoas1038
• 发表时间: 2017
• 期刊: The annals of applied statistics
• 作者: Garcia,TanyaP;Ma,Yanyuan;Marder,Karen;Wang,Yuanjia
• 通讯作者: Wang,Yuanjia