Serious adverse events in academic critical care research

Cook, Deborah; Lauzier, François; Rocha, Marcelo G.; Sayles, Mary Jane; Finfer, Simon
April 2008
CMAJ: Canadian Medical Association Journal;4/22/2008, Vol. 178 Issue 9, p1181
Academic Journal
The article discusses proposed solutions for more rational reporting of serious adverse events in academic critical care trials of drugs in common use. According to the authors, investigators must clearly describe the serious adverse events that they plan to identify and report in their protocol before commencing the trial. They added that serious adverse events must be largely limited to serious events that are known to result from the study. Moreover, to avoid attributing deaths to serious adverse events related to the study drug as the trial is unfolding, caution must be exercised.


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