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系统疾病患者的治疗方法。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。如果能有效地利用基础神经科学最近的重大发现，就有可能改变这种情况。成功和有效地开发神经系统疾病患者治疗方法所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，以及缺乏个人 培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学组织和后勤支持，从最初的概念到最终的分析，促进成人和儿童神经系统疾病的临床试验。NEXT-CCC将建立流程，大大提高多中心临床试验的效率，提高临床试验的质量，促进患者招募和保留，并增加训练有素并热衷于领导和开展多中心临床试验的临床研究者和研究人员的数量。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系统疾病临床试验。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者和研究人员的队伍，这些人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和项目团队主要研究者合作，参与和动员联邦、行业、基金会和患者合作伙伴，通过网络组织神经系统疾病的高影响力临床试验。 公共卫生相关性：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。创建一个高效的CCC，并配备一个中央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，将加快将理解疾病过程的突破转化为神经系统疾病患者的治疗。

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.