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Is There a Role for Surrogate Markers in the Evaluation of Sepsis Trials?

  • J. Cohen
Conference paper
  • 124 Downloads
Part of the Yearbook of Intensive Care and Emergency Medicine book series (YEARBOOK, volume 1998)

Abstract

The successive failure of a number of clinical trials of experimental agents in sepsis or septic shock is now an all too familiar theme, and one which has generated much discussion. Many investigators have given considerable thought to possible explanations, including incorrect reasoning (i.e., poor basic science), ineffective drugs, and poor trial design. One aspect is the question of endpoints, and the use of 28-day mortality as the ‘gold standard’ of success or failure of a new drug. Many have questioned the wisdom of this approach, arguing that death is too blunt a tool, and that we may be missing potentially useful therapies by demanding too much efficacy, too soon. The way to avoid this problem, they say, is to accept surrogate markers as valid endpoints, i.e., to find a more amenable measurement than death. In this paper, I will discuss some of the issues raised by this proposal, and show some of the advantages, and disadvantages, that it might offer.

Keywords

Septic Shock Surrogate Marker Acute Respiratory Distress Syndrome Acquire Immune Deficiency Syndrome Negative Blood Culture 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer-Verlag Berlin Heidelberg 1998

Authors and Affiliations

  • J. Cohen

There are no affiliations available

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