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2/1 Arrest Respiratory Failure due to Pneumonia (ARREST PNEUMONIA)

2/1 因肺炎导致呼吸衰竭（ARREST PNEUMONIA）

基本信息

批准号：
10701727
负责人：
MANISHA DESAI
金额：
$ 37.6万
依托单位：
STANFORD UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-15 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10701727
关键词：
Acute Award Biological Biometry Biostatistics Shared Resource Budesonide Clinical Clinical Investigator Clinical Research Clinical Trials Clinical Trials Design Collaborations Data Data Analyses Data Coordinating Center Data Scientist Data Set Databases Double-Blind Method Ensure Etiology Event Fastic Goals Housing Hypoxemia Information Technology Infrastructure Inhalation Inhalation Therapy Malignant Neoplasms Measures Medicine Methods Mission Modernization Monitor National Heart, Lung, and Blood Institute Online Systems Phase III Clinical Trials Philosophy Placebo Control Pneumonia Prevention Quality Control Randomized Reporting Research Research Design Research Personnel Research Project Grants Resource Sharing Respiratory Failure Risk Safety Scheme Science Secure Silicon Site Statistical Models Structure Techniques Technology Time Universities Work arm clinical center complex data data management data quality data sharing design efficacy testing experience formoterol innovation lung injury medical schools member open source operation success translational scientist treatment as usual treatment effect web-based tool

项目摘要

Core Summary/Abstract The Arrest Respiratory Failure due to Pneumonia (ARREST PNEUMONIA) Data Coordinating Center (DCC) will fulfill an essential need to ensure that the ARREST Pneumonia trial will achieve its mission to establish the efficacy of ancillary therapy directly targeting the lung injury that occurs with pneumonia. Critical to carrying out the trial’s success is DCC oversight of the implementation of the study design and randomization scheme, performing the interim and final data analysis, regular data and safety monitoring reports, the timely dissemination of findings, and data and resource sharing. To meet its goals, the DCC will employ open-source secure web-based tools such as REDCap for housing data across the 10 sites and allowing web-based randomization;; appropriate statistical techniques, including methods for the analysis of time-to- event data in the presence of competing risks;; and expertise in clinical trial design and data safety monitoring. The DCC includes a stellar team with extensive experience in innovative clinical trial designs, statistical modeling, managing large and complex data sets, and monitoring data quality. Importantly, the operation of the DCC will rely heavily on the philosophy that DCC members should be fully integrated into the trial’s research team as well as in the infrastructural support in order to optimally meet the trials data-related and coordination needs. To that end, the DCC is composed of five support teams corresponding to key support functions of a biostatistics and data coordinating center. The DCC’s structure will ensure the success of the scientific goals for ARREST Pneumonia by designing and monitoring the trial, developing a database in REDCap, providing specific expertise on safety monitoring and quality control, implementing analyses, and providing principal interpretation for dissemination.

核心摘要/文摘