Pediatric Asthma Network Data coordinating Center

1999年1月，NHLBI创建了一个联邦资助的临床研究计划，以研究儿童哮喘，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加1999年9月开始工作的儿童哮喘研究和教育（CARE）网络。CARE网络成功地启动了四项临床试验：（1）一项长期早期二级哮喘预防干预方案，题为预防儿童早期哮喘（PEAK）;（2）一项描述对白三烯拮抗剂和吸入性皮质类固醇（CLIC）反应的方案;（3）一项比较三种控制性治疗方案对持续性哮喘疗效的方案[小儿哮喘控制性试验（PACT）];（4）评估两种不同的急性干预管理策略（AIMS）对反复发作的喘息患儿的治疗效果。CARE网络临床中心（CC）提交的申请介绍了CARE网络如何建立成功的基础设施来进行临床研究，审查了目前进行和/或完成的试验的进展情况，并提出了三个样本方案（BADGRE，PATO和MAXISA），CARE网络认为这些方案具有足够的科学价值，可以保证再延长五年的资助。 本申请由CARE网络数据协调中心（DCC）提交，描述了DCC的功能和活动。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性和精确度，预测样本量，选择和实施随机化方案，分析数据，开发演示文稿/出版物，准备和领导培训课程，建立认证标准，编写 （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和受试者讲义，在所有CARE网络程序和临床试验中对CC工作人员进行培训和认证，在CARE网络试验进行期间支持CC工作人员，并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持;（6）监督和管理生物样本的数据采集。

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.