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: 8240687
• 负责人: CLAUDIA A CHIRIBOGA
• 金额: $ 32.98万
• 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 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8240687
• 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. PUBLIC HEALTH RELEVANCE: Strengths of this NEXT site, supported by two CTSAs, include the ability to recruit an ethnically diverse population in adult and pediatric rare and common neurological diseases. We will develop an educational program for patients, families and investigators that will inform about the importance of clinical trials and new scientific breakthroughs and challenges.

描述（由申请人提供）：哥伦比亚大学医学中心 (CUMC)-威尔康奈尔医学中心 (WCMC) NEXT 站点将通过创建共享基础设施来提高 NINDS 赞助的临床研究的效率，该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进行 II 期探索性试验，其中一些可能是生物标志物知情的。这两个神经科学中心在研究方面有着悠久的合作历史；各自的医院合并（纽约长老会医院）；它们都在区域联盟中建立了 CTSA。我们的目标是： 1) 在 CUMC（中心）和 WCMC（辐射）建立一个神经科学临床试验中心，利用成人和儿科神经病学、神经外科、基础神经科学和神经流行病学方面的丰富专业知识，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 和每个中心临床试验办公室的资源，有效地识别和招募不同种族的参与者，并迅速招募并跟踪试验完成； 3）培养下一代临床和基础神经科学家成为独立研究者，利用新技术和试验方法设计和进行临床试验； 4) 在国家层面参与 NEXT 网络并为其做出贡献。我们已经确定了具有 NIH、行业和基金会支持的临床试验经验、与基金会合作并致力于指导的联合研究人员。我们利用各自的社区、门诊护理网络和先进的生物信息学，针对罕见和更常见的神经系统疾病制定了招募策略。我们的招聘工作将与我们的三管齐下的目标相吻合：1）通过双语（英语和西班牙语）针对特定疾病的计划对家庭进行教育，2）为倡导者建立一个临床研究学习机构，3）为教师职业发展组织一个多方面的计划。大量 SMA 人群 (n=106) 以及 SMA 生物标志物研究的成功注册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。 公共卫生相关性：该 NEXT 网站的优势由两个 CTSA 支持，包括能够招募成人和儿童罕见和常见神经系统疾病的不同种族人群。我们将为患者、家属和研究人员制定一项教育计划，让他们了解临床试验的重要性以及新的科学突破和挑战。