Data Coordinating Center for the NHLBI Asthma Network (AsthmaNet)

NHLBI 哮喘网络数据协调中心 (AsthmaNet)

• 批准号: 8103168
• 负责人: David T. Mauger
• 金额: $ 779.65万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8103168
• 关键词: Acute Renal Failure with Renal Papillary Necrosis; Address; Adult; Advanced Development; Affect; Allergic; Archives; Asthma; Behavior Therapy; Birth; Case Report Form; Certification; Child; Child health care; Childhood; Chronic Disease; Clinical; Clinical Management; Clinical Research; Clinical Trials; Collaborations; Common Data Element; Communication; Communities; Community Health; Data Collection; Data Coordinating Center; Data Quality; Databases; Development; Diet; Disease; Enrollment; Exercise; Family; Fetus; Funding; Health Sciences; Home environment; Individual; Infant; Leadership; Longevity; Lung; Manuals; Medical; Medicine; Monitor; National Heart, Lung, and Blood Institute; National Institute of Child Health and Human Development; National Institute of Diabetes and Digestive and Kidney Diseases; Observational Study; Office of Administrative Management; Outcome; Parents; Pennsylvania; Performance; Perinatal; Persons; Physiological; Positioning Attribute; Pregnancy; Pregnant Women; Procedures; Protocols documentation; Public Health; Qualifying; Reporting; Research; Research Design; Research Infrastructure; Research Personnel; Resource Sharing; Resources; Role; Sample Size; Staging; Standardization; Statistical Data Interpretation; Strategic Planning; System; Telephone; Training; Translational Research; United States National Institutes of Health; Universities; Wheezing; Work; Writing; aged; clinical care; college; design; dissemination research; environmental intervention; experience; family influence; flexibility; improved; meetings; novel; novel strategies; operation; protocol development; randomized trial; symposium

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.

描述（由申请人提供）： 哮喘影响超过2200万人，是儿童最常见的慢性疾病之一。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生治疗哮喘的新方法。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;允许旨在促进新疗法和转化研究开发的研究的灵活性;促进科学交流，资源利用和跨网络标准化;促进研究成果向医学界的快速传播。AsthmaNet将包括多个临床中心（CC）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）提议担任AsthmaNet的DCC。DCC将在AsthmaNet研究的所有阶段发挥核心作用，从设计和开发到实施，分析和传播结果。具体而言，DPHS将;（1）为所有研究提供统计和数据分析专业知识，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CC提供科学协调，包括与AsthmaNet研究者合作制定和实施方案，格式化每个方案的数据收集表格，准备和领导培训课程，建立AsthmaNet程序的认证标准，并编写操作手册;（5）监控和评估方案执行和数据质量，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，以标准化通用数据元素和实践，提高运营效率;（9）管理NHLBI方案资金并将其分配给CC;以及（10）准备公共使用文件，用于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等资源。