Clinical Coordinating Center Network of Excellence in Neuroscience Clinical Trial

神经科学临床试验卓越网络(NEXT)倡议的长期目标是 迅速有效地将神经科学的进步转化为神经性疾病患者的治疗 精神错乱。急性和慢性神经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 被有效地利用。成功和有效地开发针对慢性病患者的治疗方法面临的挑战 神经性疾病包括监管和机构审批效率低下；各种障碍 招募受试者减缓了临床研究的速度，缺乏经过培训和准备进行临床研究的个人 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 通过归根结底的分析，临床试验通过在成人和儿童神经疾病中提供有效的 方法、组织和后勤支助。Next-CCC将建立以下流程： 大幅提高多中心临床试验效率，提高临床试验质量 招募和留住患者，并增加临床研究人员和研究人员的数量 受过良好的培训，对领导和进行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，以 在成人和儿童人群中高效地进行高质量的神经疾病临床试验。 具体目标2是扩大有经验的临床研究人员和研究人员的人才库 准备成为多中心临床研究试验的领导者，通过提供教育、培训、资源和 职业指导。具体目标3是吸引和动员联邦、行业、基金会和患者 合作伙伴与指导委员会、Next-DCC和项目组首席调查员合作，以 通过网络组织高影响力的神经疾病临床试验。 相关性(请参阅说明)： 尽管对几种神经性疾病的病因了解有了进步，但仍有许多没有。 有意义的治疗选择。创建具有中央IRB、主TNAL协议、 设计、实施和报告临床试验的严谨和创新流程将加快翻译 在了解疾病过程到治疗神经系统疾病方面的突破。

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.