Pediatric Asthma Network Data coordinating Center

1999年1月，NHLBI创建了一个由联邦政府资助的研究儿童哮喘的临床研究计划，并竞争性地选择了5个学术临床中心和一个数据协调中心参与1999年9月开始工作的儿童哮喘研究和教育(CARE)网络。CARE网络成功启动了四项临床试验：(1)题为《预防儿童早期哮喘(PEACT)》的长期早期二次哮喘预防干预方案；(2)表征对白三烯拮抗剂和吸入皮质类固醇(CLIC)的反应的方案；(3)正面比较三种控制方案对持续性哮喘的疗效的方案[儿科哮喘控制器试验(PACT)]；以及(4)评估两种不同急性干预管理策略(AIMS)对反复喘息并伴有明显发病率的幼儿的方案。CARE网络临床中心(CCS)提交的申请介绍了CARE网络如何建立了进行临床研究的成功基础设施，审查了当前进行和/或完成的试验的进展情况，并提出了CARE网络认为具有足够科学价值的三个样本方案(BADGRE、PATO和MAXISA)，以保证再延长五年的资金。 本申请书由CARE网络数据协调中心(DCC)提交，介绍了DCC的职能和活动。DCC的六个具体目标如下：(1)为CARE网络提供生物统计领导和科学协调，例如优化试验设计以提高准确度和精确度，预测样本量，选择和实施随机化方案，分析数据，编写演示/出版物，准备和领导培训班，建立认证标准，编写手册 (2)建立和维护CARE网络计算机网络和网站；(3)设计和维护基于广域网络和万维网实施的CARE网络数据管理系统；(4)开发和维护CARE网络数据质量保证和监测计划，例如开发高质量的数据收集表格、MOP和主题讲义，在所有CARE网络程序和临床试验中培训和认证CC工作人员，在CARE网络试验期间支持CC工作人员，以及进行现场访问和数据审计；(5)为CARE网络提供项目管理和行政支助；(6)监督和管理从生物样本获取数据。

In January 1999, the NHLBI created a federally sponsored clinical research program to study childhood asthma and competitively selected 5 academic Clinical Centers and a Data Coordinating Center to participate in the Childhood Asthma Research and Education (CARE) Network that began work in September 1999. The CARE Network successfully initiated four clinical trials: (1) a long-term early secondary asthma prevention intervention protocol entitled Prevention of Early Asthma in Kids (PEAK); (2) a protocol to characterize the response to a leukotriene antagonist and an inhaled corticosteroid (CLIC); (3) a protocol to compare head-to-head the efficacy of three controller treatment regimens for persistent asthma [Pediatric Asthma Controller Trial (PACT)]; and (4) a protocolto evaluate two different acute intervention management strategies (AIMS) for young children with recurrent episodes of wheezing associated with significant morbidity. The application submitted by the CARE Network Clinical Centers (CCs) presents how the CARE Network has established a successful infrastructure to conduct clinical research, reviews progress made with the currently conducted and/or completed trials, and presents three sample protocols (BADGRE, PATO, and MAXISA) that the CARE Network considers to be of sufficient scientific merit to warrant renewed funding for an additional five years. This application submitted by the CARE Network Data Coordinating Center (DCC) describes the function and activities of the DCC. The six specific aims of the DCC are as follows: (1) provide biostatistical leadership and scientific coordination for the CARE Network, such as optimizing trial designs for increased accuracy and precision, projecting sample sizes, selecting and implementing randomization schemes, analyzing data, developing presentations/publications, preparing and leading training sessions, establishing certification criteria, writing the Manuals of Operations (MOPs), collaborating on recruitment/retention strategies, and resolving questions from the CCs; (2) establish and maintain the CARE Network computer network and website; (3) design and maintain the CARE Network data management system based on a wide-area network and world-wide web implementation; (4) develop and maintain the CARE Network data quality assurance and monitoring program, such as developing high-quality data collection forms, MOPs, and subject handouts, training and certifying CC staff in all CARE Network procedures and clinical trials, supporting CC staff during the conduct of CARE Network trials, and performing site visits and data audits; (5) provide project management and administrative support for the CARE Network; (6) provide oversight and management of data acquisition from biological samples.