Neurological Emergencies Treatment Trials Network Statistical and Data Management

描述（由申请人提供）：NETT网络的总体目标是建立一个急诊医学、神经病学和神经外科临床医生的研究网络，以提高急性神经系统疾病患者治疗的临床试验的设计、实施和分析的效率。为了实现这一目标，NINDS规划了一个研究基础设施：(1)一个临床协调中心（CCC），为NETT的活动提供全面的领导和协调；（二）统计和数据管理中心；(3)临床中心（以轮辐模式）招募和治疗研究受试者；(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的角色是与参与网络的各方建立合作关系，并为网络在拨款期间进行的两项大型III期临床试验的设计和分析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）生物统计学、生物信息学和流行病学系（DB2E）内的数据协调单位（DCU）的支持下，我们有能力胜任这一角色，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网络的数据和项目管理系统，其中现场研究人员直接确保高数据质量；学习活动协调高效，学习信息实时提供给授权人员。作为SDMC，我们的目标是促进和促进NETT网络的研究活动，并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)与网络参与者建立合作关系；(2)积极参与规划和开展两项由网络制定并经咨询小组批准的大型神经急症临床试验；(3)使用WebDCU系统开发和实施基于网络的数据库，以进行数据输入和管理，并促进临床试验中心的工作；（四）对临床试验的安全性和有效性数据进行中期和期末统计分析；(5)向督导委员会及资管局提交报告；(6)与指导委员会和网络调查人员合作，以摘要介绍、手稿出版物的形式以及通过向公众开放的试验网站传播研究结果。

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.