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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

基本信息

批准号：
8239805
负责人：
MERIT E CUDKOWICZ
金额：
$ 274.1万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
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/8239805
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 Metric 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

项目摘要

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.

描述（由申请人提供）：神经科学临床试验卓越网络（NEXT）计划的长期目标是快速有效地将神经科学的进展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。如果最近在基础神经科学方面的重大发现能够得到有效利用，这种情况是有可能改变的。成功和有效地开发针对神经系统疾病患者的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，以及个体短缺