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Sepsis study failure highlights need for trial design rethink

Sepsis study failure highlights need for trial design rethink community-acquired pneumonia or BIOBUSINESS BRIEFS peritonitis — or specific biomarkers to identify patients who are likely to benefit TRIAL WATCH from the intervention,” agrees Opal. “We have to come up with a strategy to use rapid nucleic acid-based diagnostics Sepsis study failure highlights and other ‘omics’ approaches to pick out potentially responsive patients with an need for trial design rethink attributable risk of sepsis mortality, along with immune phenotyping of patients and The failure of Eisai’s eritoran to improve Steven Opal, Division of Biology and their likelihood of responding to specific survival in a Phase III trial in patients with Medicine, Brown University, Rhode therapies,” he adds. severe sepsis (JAMA 309, 1154–1162; 2013) Island, USA, and lead author of the paper, Such approaches could then be coupled adds to the long list of ineffective experimental attributes the failure of eritoran largely to with innovative trial designs incorporating treatments for such patients. It also suggests the underlying hypothesis being incorrect, parallel arms with different interventions that a complete rethink is needed in the and suggests some explanations. “It might and/or drug doses. “We need better surrogate strategies to evaluate novel agents for sepsis. be too late to use this kind http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Nature Reviews Drug Discovery Springer Journals

Sepsis study failure highlights need for trial design rethink

Tse, Man Tsuey
Nature Reviews Drug Discovery , Volume 12 (5) – May 1, 2013
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Sepsis study failure highlights need for trial design rethink

Abstract

community-acquired pneumonia or BIOBUSINESS BRIEFS peritonitis — or specific biomarkers to identify patients who are likely to benefit TRIAL WATCH from the intervention,” agrees Opal. “We have to come up with a strategy to use rapid nucleic acid-based diagnostics Sepsis study failure highlights and other ‘omics’ approaches to pick out potentially responsive patients with an need for trial design rethink attributable risk of sepsis mortality, along with immune...
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References (1)

Publisher
Springer Journals
Copyright
Copyright © Springer Nature Limited 2013
Subject
Biomedicine; Biomedicine, general; Pharmacology/Toxicology; Biotechnology; Medicinal Chemistry; Molecular Medicine; Cancer Research
ISSN
1474-1776
eISSN
1474-1784
DOI
10.1038/nrd4016
Publisher site
See Article on Publisher Site

Abstract

community-acquired pneumonia or BIOBUSINESS BRIEFS peritonitis — or specific biomarkers to identify patients who are likely to benefit TRIAL WATCH from the intervention,” agrees Opal. “We have to come up with a strategy to use rapid nucleic acid-based diagnostics Sepsis study failure highlights and other ‘omics’ approaches to pick out potentially responsive patients with an need for trial design rethink attributable risk of sepsis mortality, along with immune phenotyping of patients and The failure of Eisai’s eritoran to improve Steven Opal, Division of Biology and their likelihood of responding to specific survival in a Phase III trial in patients with Medicine, Brown University, Rhode therapies,” he adds. severe sepsis (JAMA 309, 1154–1162; 2013) Island, USA, and lead author of the paper, Such approaches could then be coupled adds to the long list of ineffective experimental attributes the failure of eritoran largely to with innovative trial designs incorporating treatments for such patients. It also suggests the underlying hypothesis being incorrect, parallel arms with different interventions that a complete rethink is needed in the and suggests some explanations. “It might and/or drug doses. “We need better surrogate strategies to evaluate novel agents for sepsis. be too late to use this kind

Journal

Nature Reviews Drug Discovery – Springer Journals

Published: May 1, 2013

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