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

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（受益于现有资源，包括两个CTSA）来进行七项II期探索性试验和一项生物标志物研究，提高了NINDS赞助的临床研究的效率。四项研究已经完成，四项正在进行中。联合NNEXT网站由PI Karen Marder M.D.领导。Claudia Chiriboga M.D. MPH在WCMC，现在，象征着WCMC和WCMC之间的协同作用，克莱尔亨奇克利夫医学博士。WCMC的DPhil将作为PI加入。这两个神经科学中心在研究方面有着悠久的合作历史;它们各自的医院合并在一起（纽约长老会医院），它们都有CTSA在一个地区联盟NYCON中联系起来。自2011年以来，我们的机构通过强调精准医学的“我们所有人”计划加强了彼此的关系。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，在我们的联合神经科学临床试验中心的成功基础上，能够进行计划中的5到10项NNEXT试验。我们已经制定了一个罕见和更常见的神经系统疾病的招募策略，利用我们各自的社区，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）疾病特异性计划教育家庭。我们将在招募保留核心的指导下，由具有专业知识（少数民族招募，流行病学）的个人组成，为NEXT试验者提供实用的实时问题解决方案。2)利用CTSA、临床试验办公室、IRB和研究合规与培训办公室的资源，在每个研究中心有效识别并快速招募不同种族的受试者，随访至试验完成。3)通过开发我们自己的临床试验，参与并为NNEXT网络做出贡献。我们已经在两个研究中心确定了一个共同研究者团队，他们在NIH、行业和基金会支持的临床试验方面有经验，已经证明了与基金会的合作关系，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，能够设计和进行临床试验，并受益于新技术和试验方法。为此，我们将为教师职业发展组织一个多方面的计划。5)改善向患者，家庭和特定疾病倡导者传播有关科学进步和临床试验在我们社区的重要性的信息，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，以接触更广泛的公众。

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.