Clinical Coordinating Center Network of Excellence in Neuroscience Clinical Trial

描述(由申请人提供)：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神经疾病患者的治疗。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得到有效利用，就有可能改变这一状况。神经疾病治疗方法的成功和有效开发面临的挑战包括监管和机构审批效率低下，招募受试者的各种障碍减缓了临床研究，以及个人短缺。 受训并准备领导多中心临床研究。临床协调中心(NEXT-CCC)的主要目标是通过提供有效的方法、组织和后勤支持，从最初的构思到最终分析，促进成人和儿童神经疾病的临床试验。Next-CCC将建立流程，极大地提高多中心临床试验的效率，改善临床试验的质量，促进患者招募和留住，并增加训练有素、对领导和进行多中心临床试验充满热情的临床研究人员和研究人员的数量。具体目标1是创建一个协作的临床协调中心和网络基础设施，以有效地在成人和儿童人群中进行高质量的神经疾病临床试验。具体目标2是通过提供教育、培训、资源和专业指导，扩大有经验的临床研究人员和研究人员的人才库，他们准备成为多中心临床研究试验的领导者。具体目标3是通过与指导委员会、Next-DCC和项目组首席调查员合作，通过该网络组织高影响力的神经疾病临床试验，从而吸引和动员联邦、行业、基金会和患者合作伙伴。 与公共卫生相关：尽管在了解几种神经疾病的原因方面取得了进展，但许多人仍然没有有意义的治疗选择。创建一个具有中央IRB、主试验协议以及设计、实施和报告临床试验的严格和创新流程的高效CCC，将加速将在了解疾病过程方面的突破转化为神经疾病患者的治疗。

DESCRIPTION (provided by applicant): The long-term objective of the Network of Excellence in Neuroscience Clinical Trials (NEXT) initiative is to rapidly and efficiently translate advances n 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 f 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 of the 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 clinica 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 trials. 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 professiona mentorship. Specific Aim 3 is to engage and mobilize federal, industry, foundation 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. PUBLIC HEALTH RELEVANCE: 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 trial 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.