Columbia University Medical Center - Weill Cornell Medical Center NEXT Site

哥伦比亚大学医学中心 - 威尔康奈尔医学中心 下一个站点

• 批准号: 8729623
• 负责人: CLAUDIA A CHIRIBOGA
• 金额: $ 27.42万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-30 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8729623
• 关键词: Academic Medical Centers; Adult; Advocate; Ambulatory Care; Bioinformatics; Biological Markers; Childhood; Clinical; Clinical Research; Clinical Trials; Collaborations; Communities; Conduct Clinical Trials; Disease; Enrollment; Faculty; Family; Foundations; Goals; Hospitals; Industry; Institutes; Institutional Review Boards; Learning; Link; Longevity; Medical center; Mentorship; Methodology; National Institute of Neurological Disorders and Stroke; Neurosciences; New York; Participant; Patients; Pediatric Neurology; Phase; Phase II Clinical Trials; Population; Population Heterogeneity; Presbyterian Church; Recording of previous events; Recruitment Activity; Research; Research Infrastructure; Research Personnel; Resources; Scientific Advances and Accomplishments; Site; Training; United States National Institutes of Health; Validation; career development; design; experience; medical schools; nervous system disorder; neurosurgery; new technology; next generation; programs; validation studies

DESCRIPTION (provided by applicant): The Columbia University Medical Center (CUMC)-Weill Cornell Medical Center (WCMC) NEXT site will increase the efficiency of clinical research sponsored by NINDS through the creation of a shared infrastructure that will benefit from existing resources, including two CTSAs, to conduct Phase II exploratory trials, some of which may be biomarker-informed, in partnership with industry and foundations. 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. Our aims are: 1) to develop a neuroscience clinical trials site at CUMC (hub) and WCMC (spoke) that draws from extensive expertise in adult and pediatric neurology, neurosurgery, basic neuroscience, and neuroepidemiology and that is capable of conducting five to seven Phase II clinical trials or biomarker validation studies across its lifespan; 2) to leverage resources from the CTSA and Office of Clinical Trials at each center to efficiently identify and recruit ethnically diverse participants who are expeditiously recruited and followed to trial completion; 3) to train the next generation of clinical and basic neuroscientists to become independent investigators who will design and conduct clinical trials, making use of new technologies and trial methodologies; and 4) to participate in, and contribute to, the NEXT network on a national level. We have identified co-investigators who have experience in NIH-, industry- and foundation-supported clinical trials, demonstrated partnership with foundations, and a commitment to mentorship. 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: 1) educate families through bilingual (English and Spanish) disease-specific programs, 2) develop a clinical-research learning-institute for advocates, and 3) organize a multifaceted program for faculty career-development. The large SMA population (n=106) and demonstrated successful enrollment in the Biomarker for SMA study provides us with the necessary experience to conduct the anticipated NEXT SMA biomarker validation trial.

描述（由申请人提供）：哥伦比亚大学医学中心（CDC）-威尔康奈尔医学中心（WCMC）NEXT研究中心将通过创建共享基础设施（将受益于现有资源，包括两个CTSA），与行业和基金会合作开展II期探索性试验（其中一些可能是生物标志物知情试验），提高NINDS申办的临床研究的效率。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在一个地区联盟中联系起来。我们的目标是：1）在WCMC（中心）和WCMC（分支）建立一个神经科学临床试验网站，该网站借鉴了成人和儿童神经病学，神经外科，基础神经科学和神经流行病学的广泛专业知识，并能够在其生命周期内进行五到七项II期临床试验或生物标志物验证研究; 2）利用CTSA和每个中心的临床试验办公室的资源，有效地识别和招募种族多样的参与者，并迅速招募和跟踪试验完成; 3）培养下一代临床和基础神经科学家成为独立的研究者，他们将设计和进行临床试验，利用新技术和试验方法; 4）参与并促进国家一级的NEXT网络。我们已经确定了合作研究者，他们在NIH，行业和基金会支持的临床试验中有经验，与基金会建立了合作伙伴关系，并致力于指导。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：1）通过双语（英语和西班牙语）疾病特定计划教育家庭，2）为倡导者开发临床研究学习机构，3）组织教师职业发展的多方面计划。SMA生物标志物研究中的大型SMA人群（n=106）和成功入组为我们提供了进行预期的NEXT SMA生物标志物验证试验所需的经验。