Neurological Emergencies Treatment Trials Network Statistical and Data Management

描述(申请人提供)：NETT网络的总体目标是创建急诊医学、神经病学和神经外科临床医生的研究网络，以提高设计、实施和分析治疗急性神经性疾病患者的临床试验的效率。为了实现这一努力，NINDS规划了一个研究基础设施：(1)临床协调中心(CCC)，以全面领导和协调NETT的活动；(2)统计和数据管理中心(SDMC)；(3)临床中心(以中心和辐射型模式)，以招募和治疗研究对象；以及(4)NINDS，通过数据和安全监测委员会(DSMB)和外部咨询小组提供科学投入和监督。SDMC的作用是与网络中涉及的所有各方建立合作关系，并在网络将在赠款期间进行的两个大型第三阶段临床试验的设计和分析中提供有效的数据管理和统计贡献。在南卡罗来纳医科大学(MUSC)生物统计、生物信息学和流行病学系(DB2E)数据协调股(DCU)的支持下，我们完全有能力填补这一角色，并与临床团队合作进行这些试验。我们在指导类似类型的大型多中心临床研究的统计和数据协调中心方面的经验使我们能够开发基于Web的数据和项目管理系统，其中高数据质量由现场研究人员直接确保；研究活动高效协调，研究信息实时提供给授权人员。作为国家经贸委，我们的目标是促进和促进NETT网络研究活动，为合作研究做出贡献。作为NETT网络的SDMC，我们将实现以下目标：(1)与NETT网络参与者建立合作关系；(2)积极参与由NETT网络开发并经咨询小组批准的两项大型神经急症临床试验的策划和进行；(3)利用WebDCU系统开发和实施基于Web的数据库，用于数据输入和管理，并促进临床试验中心的工作；(4)对临床试验的安全性和有效性数据进行中期和最终统计分析；(5)向指导委员会和战略规划和预算编制局提交报告；和(6)与指导委员会和网络调查员合作，以摘要介绍、手稿出版物的形式以及通过公众可访问的试验网站传播研究成果。

DESCRIPTION (provided by applicant): The overall goal of the NETT Network is to create a research network of clinicians in emergency medicine, neurology and neurosurgery to promote efficiency in the design, implementation and analysis of clinical trials of therapies for patients with acute neurological disorders. To achieve this endeavor, the NINDS has planned a research infrastructure with: (1) a clinical coordinating center (CCC) to provide overall leadership and coordination of activities of the NETT; (2) a statistical and data management center (SDMC); (3) clinical centers (in a hub and spoke model) to recruit and treat study subjects; and (4) the NINDS to provide scientific input and oversight through a Data and Safety Monitoring Board (DSMB) and an external advisory group. The SDMC's role is to establish a collaborative relationship with all parties involved in the Network and provide efficient data management and statistical contribution in the design and analysis of the two large Phase III clinical trials to be conducted by the Network during the grant period. With the support of the Data Coordination Unit (DCU) housed within the Department of Biostatistics, Bioinformatics and Epidemiology (DB2E) at the Medical University of South Carolina (MUSC), we are well-equipped to fill this role and partner with the clinical teams on these trials. Our experience in directing statistical and data coordinating center for large multicenter clinical studies of similar type has enabled us to develop web-based data and project management systems in which high data quality is ensured directly by site research staff; study activities are coordinated with high efficiency and study information is available to authorized personnel in real time. As the SDMC, our goal is to promote and facilitate the NETT Network research activities and contribute to collaborative research. As the SDMC for the NETT Network, we will accomplish the following aims: (1) to establish a collaborate relationship with the Network participants; (2) to actively contribute to the planning and conduct of two large clinical trials of neurological emergencies to be developed by the Network and approved by the Advisory Group; (3) to develop and implement the web-based databases using the WebDCU system for data entry and management and to facilitate the work of the CCC for the clinical trials; (4) to conduct interim and final statistical analyses of safety and efficacy data of the clinical trials; (5) to generate reports to the Steering Committee and the DSMB; and (6) in collaboration with the Steering Committee and the Network investigators, disseminate the study results in the form of abstract presentations, manuscript publications, and through the trial websites accessible to the public.