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网站通过创建受益于现有资源的共享基础设施，提高了NINDS赞助的临床研究的效率，其中包括两项CTSA，以进行七项II期探索性试验和一项生物标记物研究。四项研究已经完成，四项正在进行中。联合的nNext网站一直由CUMC的Pis Karen Marder M.D.公共卫生硕士和Claudia Chiriboga M.D.公共卫生硕士领导，现在，象征着CUMC和WCMC之间增强的协同作用，WCMC的Claire Henchcliffe M.D.DPhil将作为PI加入。这两个神经科学中心在研究方面有着长期的合作历史；它们各自的医院被合并(纽约长老会医院)，它们都有CTSA连接在一个地区性财团NYCON中。自2011年以来，我们的机构通过强调精密医疗的“我们所有人”计划，加强了它们之间的关系。我们的目标是1)借助我们在成人和儿科神经病学、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CUMC-WCMC临床试验站点取得成功的基础上，能够进行计划中的5到10个Next试验。我们利用我们各自的社区、门诊护理网络和先进的生物信息学，为罕见和更常见的神经疾病制定了招募战略。我们的招聘工作将与我们通过双语(英语和西班牙语)疾病专项计划教育家庭的三管齐下的目标相吻合。我们将以招聘保留核心为指导，该核心由具有专业知识(少数民族招聘、流行病学)的个人组成，为下一批试验者提供实用的实时问题解决方案。2)在每个中心利用CTSA、临床试验办公室、IRB和研究合规与培训办公室的资源，有效地确定并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，参与并贡献NNext网络。我们已经在这两个地点确定了一个联合调查团队，他们在NIH、行业和基金会支持的临床试验方面拥有经验，展示了与基金会的合作伙伴关系，并致力于指导。包括高级领导层在内的下一个咨询委员会将就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人员，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，以及包括远程医疗在内的创新手段，更好地向患者、家属和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，以接触到更广泛的公众。

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.