Network of Excellence in Neuroscience Clinical Trials (NEXT)-DCC

描述（由申请人提供）：临床试验的成功进行需要临床协调中心（CCC）、数据协调中心（DCC）和受试者入组和随访的临床站点之间的良好合作。人们很难找到很多例子来说明，尽管关系不好，但项目还是取得了成功。然而，在不同的个人群体之间发展成功的协作关系是一个困难且资源密集的过程。创建新联盟和培养新关系所需的不成比例的资源是进行多中心临床试验的常见方法的一个限制方面。神经科学临床试验卓越网络（NEXT）将提供许多临床试验可以利用的共同可重用资源。本申请请求资金支持在爱荷华大学创建DCC。DCC将支持研究设计、数据收集、数据管理、项目管理、临床现场监测、质量管理、安全监测和拟议试验的统计方面。DCC申请的具体目的是：1)提供研究设计和统计领导；2)开发和维护基于web的分布式数据录入系统，具有快速、高效、准确的随机化能力

DESCRIPTION (provided by applicant): The successful conduct of clinical trials requires an excellent collaboration between a Clinical Coordinating Center (CCC), a Data Coordinating Center (DCC), and the clinical sites where subjects are enrolled and followed. One would be hard pressed to find many examples of projects that succeeded in spite of poor relationships. However, developing successful collaborative relationships among diverse groups of individuals is a difficult and resource intensive process. The disproportionate amount of resources required to create de novo consortiums and cultivate new relationships is one limiting aspect of the common approach to conducting multi-center clinical trials. The Network of Excellence in Neuroscience Clinical Trials (NEXT) will provide common reusable resources that many clinical trials can leverage. This application requests funds to support the creation of a DCC at the University of Iowa. The DCC will support study design, data collection, data management, project management, clinical site monitoring, quality management, safety monitoring, and statistical aspects of the proposed trial. The specific aims of the DCC application are to: 1) Provide study design and statistical leadership; 2) Develop and maintain a web-based distributed data entry system with the capability to quickly, efficiently, and accurately randomize subjects and collect data generated by the studies conducted within the network; 3) Provide project management support for the studies conducted within the network; and 4) Provide access to study-wide and network information. The DCC will provide a robust, standardized, and accessible infrastructure to facilitate rapid development and implementation of protocols for conducting clinical trials in neuroscience. Additionally, the proposed DCC infrastructure is explicitly designed to accommodate dynamically changing requirements that naturally occur in clinical trials (both planned and unplanned). The proposed DCC will provide more rapid evaluation of promising treatments in neuroscience, and will be a model that can be replicated across a number of studies and diseases.