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. 2008 Nov;34(11):1935-47.
doi: 10.1007/s00134-008-1266-6. Epub 2008 Oct 7.

Design, conduct, analysis and reporting of a multi-national placebo-controlled trial of activated protein C for persistent septic shock

Simon Finfer  1 , V Marco Ranieri, B Taylor Thompson, Philip S Barie, Jean-François Dhainaut, Ivor S Douglas, Bengt Gårdlund, John C Marshall, Andrew Rhodes
Affiliations

Design, conduct, analysis and reporting of a multi-national placebo-controlled trial of activated protein C for persistent septic shock

Simon Finfer et al. Intensive Care Med. 2008 Nov.

Erratum in

  • Intensive Care Med. 2011 Feb;37(2):372

Abstract

The role of drotrecogin alfa (activated) (DAA) in severe sepsis remains controversial and clinicians are unsure whether or not to treat their patients with DAA. In response to a request from the European Medicines Agency, Eli Lilly will sponsor a new placebo-controlled trial and history suggests the results will be subject to great scrutiny. An academic steering committee will oversee the conduct of the study and will write the study manuscripts. The steering committee intends that the study will be conducted with the maximum possible transparency; this includes publication of the study protocol and a memorandum of understanding which delineates the role of the sponsor. The trial has the potential to provide clinicians with valuable data but patients will only benefit if clinicians have confidence in the conduct, analysis and reporting of the trial. This special article describes the process by which the trial was developed, major decisions regarding trial design, and plans for independent analysis, interpretation and reporting of the data.

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Figures

Fig. 1
Fig. 1
Cumulative mortality rate over time in the PROWESS trial. Solid black lines, drotrecogin alfa (activated) group; solid grey lines, placebo group. The amended version of the protocol was introduced at Line A, first interim analysis occurred at Line B and the second interim analysis at Line C. (Reproduced from Critical Care Medicine 2004;32(12):2388 with permission)
See this image and copyright information in PMC

Comment in

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