Clinical Coordinating Center Network of Excellence in Neuroscience Clinical Trial

神经科学临床试验卓越临床协调中心网络

• 批准号: 9069323
• 负责人: MERIT E CUDKOWICZ
• 金额: $ 10.26万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 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 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9069323
• 关键词: Acute; Adherence; Adult; Adverse event; Agreement; Bylaw; Childhood; Chronic; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Conceptions; Contracts; Data Coordinating Center; Development; Disease; Education; Ensure; Fostering; Foundations; Goals; Individual; Industry; Information Technology; Institutional Review Boards; Intervention; Joints; Laboratories; Lead; Mentorship; Monitor; Multicenter Trials; Neurosciences; Outcome Measure; Patient Recruitments; Patients; Pharmacy facility; Population; Principal Investigator; Procedures; Process; Protocols documentation; Reporting; Research; Research Infrastructure; Resources; Site; Societies; Telemedicine; Training; Training Programs; Training and Education; Translating; Translations; Work; design; experience; human subject protection; improved; innovation; nervous system disorder; organizational structure; performance site; protocol development; therapy development; tool

The long-term objective ofthe Network of Excellence in Neuroscience Clinical Trials (NEXT) initiative is to rapidly and efficiently translate advances in neuroscience into treatments for people with neurological disorders. Acute and chronic neurological disorders impose a massive burden on both patients and society. The potential exists to change this situation if recent major discoveries in basic neuroscience can be exploited effectively. Challenges to the successful and efficient development of treatments for people with neurological disorders include inefficiencies in regulatory and institutional approvals; a variety of barriers to recruitment of subjects that slow down clinical research and a shortage of individuals trained and prepared to lead multicenter clinical research. The primary goal ofthe Clinical Coordinating Center (NEXT-CCC) is to facilitate, from initial conception through final analysis, clinical trials in adult and pediatric neurological disorders by providing efficient methodological, organizational and logistical support. The NEXT-CCC will establish processes that will dramatically increase the efficiency of multicenter clinical trials, improve the quality of clinical trials promote patient recruitment and retention and increase the number of clinical investigators and research staff who are well trained and passionate about leading and conducting multicenter clinical trails. Specific aim 1 is to create a collaborative Clinical Coordinating Center and network infrastructure to efficiently conduct high quality clinical trials for neurological disorders in both adult and pediatric populations. Specific aim 2 is to expand the pool of experienced clinical Investigators and research staff who are prepared to be leaders of multicenter clinical research trials by providing education, training, resources and professional mentorship. Specific aim 3 is to engage and mobilize federal, industry, foundations and patient partners by working with the Steering Committee, NEXT-DCC, and Project Team Principal Investigators to organize high impact clinical trials for neurological disorders through the network. RELEVANCE (See instructions): Despite advances in understanding the causes of several neurological disorders, many remain without meaningful treatment options. The creation of an efficient CCC with a central IRB, master tnal agreement, and rigorous and innovative processes to design, implement and report clinical trials will expedite translation of breakthroughs in understanding disease processes into treatments for people with neurological disorders.

神经科学临床试验卓越网络（NEXT）倡议的长期目标是 快速有效地将神经科学的进步转化为对神经系统疾病患者的治疗。 紊乱急性和慢性神经系统疾病给患者和社会带来了巨大的负担。 如果基础神经科学的最新重大发现能够被应用于神经系统， 有效利用。成功和有效地开发针对患有糖尿病的人的治疗方法所面临的挑战 神经系统疾病包括监管和机构审批效率低下; 招募受试者减缓了临床研究的速度，缺乏受过培训和准备好 领导多中心临床研究。 临床协调中心（NEXT-CCC）的主要目标是从最初的概念开始， 通过最终的分析，在成人和儿童神经系统疾病的临床试验， 方法、组织和后勤支助。NEXT-CCC将建立程序， 大幅度提高多中心临床试验效率，提高临床试验质量，促进 患者招募和保留，增加临床研究者和研究人员的数量， 受过良好的培训，对领导和开展多中心临床试验充满热情。 具体目标1是创建协作临床协调中心和网络基础设施， 在成人和儿童人群中有效开展高质量的神经系统疾病临床试验。 具体目标2是扩大经验丰富的临床研究者和研究人员的数量， 准备通过提供教育，培训，资源和 专业指导。具体目标3是参与和动员联邦、工业、基金会和病人 通过与指导委员会、NEXT-DCC和项目团队主要研究者合作， 通过网络组织神经系统疾病的高影响力临床试验。 相关性（参见说明）： 尽管在了解几种神经系统疾病的原因方面取得了进展，但许多仍然没有 有意义的治疗方案。建立一个有效的CCC，有一个中央IRB，主协议， 设计、实施和报告临床试验的严格和创新流程将加快翻译 在理解疾病过程方面的突破，用于治疗神经系统疾病。