Data Coordinating Center for the NHLBI Asthma Network (AsthmaNet)

描述(由申请人提供)： 哮喘影响着2200多万人，是儿童最常见的慢性病之一。NHLBI正在建立AsthmaNet，这是一个临床研究网络，将开发和进行多项临床试验，以解决重要的临床管理问题和终身治疗哮喘的新方法。NHLBI的临床研究网络战略计划包括保持对改善临床护理的关注；允许旨在推动新疗法和转化性研究开发的研究的灵活性；促进跨网络的科学交流、资源利用和标准化；以及促进研究成果快速传播到医学界。AsthmaNet将包括多个临床中心(CCS)和一个数据协调中心(DCC)。宾夕法尼亚州立大学医学院的公共卫生科学系(DPHS)建议担任哮喘网络的DCC。DCC将在哮喘网络研究的所有阶段发挥中心作用，从设计和开发到实施、分析和传播结果。具体而言，新闻部将：(1)为所有研究提供统计和数据分析专门知识，包括统计设计和样本量估计；(2)建立和管理研究数据库；(3)建立和管理通信系统；(4)为CCS提供科学协调，包括与AsthmaNet调查员合作制定和实施方案，格式化每个方案的数据收集表格，准备和领导培训班，为AsthmaNet程序建立认证标准，并编写操作手册；(5)监测和评价方案执行情况和数据质量，并向NHLBI提供报告；(6)提供项目管理和行政支持，包括为所有AsthmaNet相关委员会安排会议和电话会议；(7)建立、维护和监督分包合同；(8)与NHLBI和其他参与肺部研究的网络合作，使共同的数据元素和做法标准化，以提高业务效率；(9)管理NHLBI方案资金，并将其分发给CCS；(10)为存档和共享研究结果、传播研究成果以及共享研究手册和病例报告表格等资源而准备公共使用文件。

DESCRIPTION (provided by applicant): Asthma affects more than 22 million persons and it is one ofthe most common chronic diseases of childhood. The NHLBI is establishing AsthmaNet, a clinical research network that will develop and conduct multiple clinical trials to address important clinical management questions and new approaches to treating asthma across the lifetime. The NHLBI's strategic plan for clinical research networks includes maintaining a focus on improving clinical care; allowing flexibility in research designed to advance the development of novel therapies and translational research; promoting scientific exchange, use of resources and standardization across networks; and facilitating rapid dissemination of research findings to the medical community. AsthmaNet will include multiple Clinical Centers (CCs) and one Data Coordinating Center (DCC). The Department of Public Health Sciences (DPHS) at The Pennsylvania State University College of Medicine proposes to serve as the DCC for AsthmaNet. The DCC will have a central role in all stages of AsthmaNet studies from design and development to implementation, analysis, and dissemination of results. Specifically, DPHS will; (1) provide statistical and data analysis expertise for all studies, including statistical design and sample size estimation; (2) establish and manage the study databases; (3) establish and manage a communication systems; (4) provide scientific coordination for the CCs that includes collaborating with the AsthmaNet investigators on protocol development and implementation, formatting data collection forms for each protocol, preparing and leading training sessions, establishing certification criteria for AsthmaNet procedures, and writing the manuals of operations; (5) monitor and evaluate protocol execution and quality of data and provide reports to NHLBI; (6) provide project management and administrative support, including arranging meetings and telephone conference for all AsthmaNet related committees; (7) establish, maintain, and provide oversight to subcontracts; (8) collaborate with the NHLBI and other networks involved in pulmonary research to standardize common data elements and practices to increase operational efficiency; (9) manage NHLBI protocol funds and distribute them to the CCs; and (10) prepare public-use files for archiving and sharing study results, disseminating research findings, and sharing resources such as study manuals and case-report forms.