Friday, April 26, 2024
4/26/2024
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.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).
