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：
8885926
负责人：
MERIT E CUDKOWICZ
金额：
$ 260.14万
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 2016-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8885926
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

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.

描述（由申请人提供）：神经科学临床试验卓越网络的长期目标（下一个）计划是迅速有效地将n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会给患者和社会带来巨大负担。如果可以有效利用基本神经科学的最新发现，则存在改变这种情况的潜力。对神经系统疾病患者的成功有效发展的挑战包括监管和机构批准效率低下经过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论组织和后勤支持，从最初的构想到最终分析，成人和小儿神经系统疾病的临床试验。下一个CCC将建立将大大提高多中心临床试验效率，提高临床试验质量，促进患者招聘和保留率的效率，并增加对领导和进行多中心临床试验的领导和进行良好的临床研究人员的数量，并增加临床招聘和保留的效率。具体目标1是创建一个协作临床协调中心和网络基础设施，以有效地进行成人和儿科人群神经疾病的高质量临床试验。具体目标2是扩大经验丰富的临床研究人员和研究人员，他们准备通过提供教育，培训，资源和专业指导来成为多中心临床研究试验的领导者。特定目标3是通过与指导委员会，隔壁DCC和项目团队首席研究人员合作，通过网络组织神经系统疾病的高影响力临床试验来参与和动员联邦，行业，基金会和患者合作伙伴。