• J. Am. Coll. Surg. · Jan 2007

    The role of data and safety monitoring in acute trauma resuscitation research.

    • Howard R Champion, Abe Fingerhut, Miguel A Escobar, and Richard B Weiskopf.
    • Uniformed Services University of Health Sciences, Bethesda, MD 20910, USA.
    • J. Am. Coll. Surg. 2007 Jan 1;204(1):73-83.

    BackgroundThe role of data and safety monitoring boards (DSMBs) in clinical research in acute trauma resuscitation is not well documented. Many of the difficulties conducting acute resuscitation research are exacerbated because multiinstitutional studies are needed to adequately power such research.Study DesignThe purpose of the study was to demonstrate how a well-organized DSMB, explicitly required for these types of clinical trials by many funding agencies, can be a valuable resource in their safe and successful conduct by maximizing data integrity and striving to standardize care by monitoring the consistent and accurate collection of data and adherence to protocol. As an example, the work of an external DSMB in an international multicenter trial of recombinant activated coagulation factor VIIa (rFVIIa) in blunt and penetrating trauma patients is presented. The DSMB in this study was responsible for reviewing all serious adverse event (SAE) data, performing an extended review of SAEs, and reviewing results of analyses of 48-hour and 30-day mortality according to prespecified study stopping rules.ResultsApplication by the DSMB of uniform definitions of SAEs substantially improved the integrity of the study data and facilitated analysis of events, such as disseminated coagulopathy, pulmonary complications, and multiple organ failure. As a result of the DSMB's efforts, important insights were gained to guide site selection and conduct of future trials of rFVIIa in trauma-induced hemorrhage.ConclusionsBased on our experience as members of the study DSMB and on a review of the literature, we recommend a strong role for DSMBs in multicenter trials in acute resuscitative care.

      Pubmed     Full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…