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The failure of clinical trials in sepsis: Challenges of pre-clinical models

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Cytokines in Severe Sepsis and Septic Shock

Part of the book series: Progress in Inflammation Research ((PIR))

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Abstract

Perhaps no clinical problem lacking effective therapy has been as extensively studied as sepsis. A MEDLINE search under the MESH heading, “sepsis”, currently yields more than 35,000 references, including in vitro studies, in vivo animal studies, and human clinical trials. To date, no effective mediator-directed therapy is available. Promising compounds, with impressive preclinical efficacy and preliminary human benefit in phase II studies, have failed to improve outcome in well-conducted phase III randomized, controlled trials. The potential reasons for these disappointing results are many [1–4]. An important factor has been the applicability of inferences drawn from pre-clinical studies.

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Authors and Affiliations

  1. Critical Care Medicine Programme, Department of Critical Care Medicine, University of Toronto, Hospital for Sick Children and Toronto Hospital, 200 Elizabeth Street, Toronto, Ontario, Canada, M5G 2C4

    David Creery & John C. Marshall

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  1. David Creery
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  2. John C. Marshall
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Editors and Affiliations

  1. Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, Donaueschingenstrasse 13, A-1200, Vienna, Austria

    Heinz Redl  & Günther Schlag  & 

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Creery, D., Marshall, J.C. (1999). The failure of clinical trials in sepsis: Challenges of pre-clinical models. In: Redl, H., Schlag, G. (eds) Cytokines in Severe Sepsis and Septic Shock. Progress in Inflammation Research. Birkhäuser, Basel. https://doi.org/10.1007/978-3-0348-8755-7_19

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  • DOI: https://doi.org/10.1007/978-3-0348-8755-7_19

  • Publisher Name: Birkhäuser, Basel

  • Print ISBN: 978-3-0348-9759-4

  • Online ISBN: 978-3-0348-8755-7

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