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Intensive Care Medicine
Published in: Intensive Care Medicine 11/2008

Open Access 01-11-2008 | Editorial

Once is not enough: clinical trials in sepsis

Authors: Daniel A. Sweeney, Robert L. Danner, Peter Q. Eichacker, Charles Natanson

Published in: Intensive Care Medicine | Issue 11/2008

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Excerpt

In this issue of Intensive Care Medicine, the steering committee members of the PROWESS-Shock trial present a balanced discussion of the controversies surrounding recombinant human activated protein C (rhAPC) and the challenges intrinsic to designing an industry-sponsored trial [1]. The investigators have taken important steps to be transparent about financial conflicts of interest, to safeguard data monitoring and to ensure the validity of statistical analysis. The purpose of the upcoming PROWESS-Shock Trial is to prospectively test rhAPC in a high-risk septic population—those patients with vasopressor-dependent shock for ≥4 h. The need for this trial, years after the regulatory approval of rhAPC for a similar indication, is a cautionary tale that contains important lessons for health care providers who manage patients with sepsis, the pharmaceutical industry and the Food and Drug Administration (FDA). …
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Metadata
Title
Once is not enough: clinical trials in sepsis
Authors
Daniel A. Sweeney
Robert L. Danner
Peter Q. Eichacker
Charles Natanson
Publication date
01-11-2008
Publisher
Springer-Verlag
Published in
Intensive Care Medicine / Issue 11/2008
Print ISSN: 0342-4642
Electronic ISSN: 1432-1238
DOI
https://doi.org/10.1007/s00134-008-1274-6

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