End points for phase II trials in intensive care: recommendations from the Australian and New Zealand Clinical Trials Group consensus panel meeting

Young, Paul, Hodgson, Carol, Dulhunty, Joel, Saxena, Manoj, Bailey, Michael, Bellomo, Rinaldo, Davies, Andrew, Finfer, Simon, Kruger, Peter, Lipman, Jeffrey, Myburgh, John, Peake, Sandra, Seppelt, Ian, Streat, Stephen, Tate, Rhiannon, Webb, Steven and The ANZICS Clinical Trials Group (2012) End points for phase II trials in intensive care: recommendations from the Australian and New Zealand Clinical Trials Group consensus panel meeting. Critical Care and Resuscitation, 14 3: 211-215.

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Name Description MIMEType Size Downloads
Author Young, Paul
Hodgson, Carol
Dulhunty, Joel
Saxena, Manoj
Bailey, Michael
Bellomo, Rinaldo
Davies, Andrew
Finfer, Simon
Kruger, Peter
Lipman, Jeffrey
Myburgh, John
Peake, Sandra
Seppelt, Ian
Streat, Stephen
Tate, Rhiannon
Webb, Steven
The ANZICS Clinical Trials Group
Total Author Count Override 366
Title End points for phase II trials in intensive care: recommendations from the Australian and New Zealand Clinical Trials Group consensus panel meeting
Journal name Critical Care and Resuscitation   Check publisher's open access policy
ISSN 1441-2772
Publication date 2012-09
Sub-type Article (original research)
Volume 14
Issue 3
Start page 211
End page 215
Total pages 5
Place of publication Strawberry Hills, NSW Australia
Publisher Australasian Medical Publishing Company
Collection year 2013
Language eng
Formatted abstract
Background: There is uncertainty about which end points should be used for Phase II trials in critically ill patients.
Objective:
To systematically evaluate potential end points for Phase II trials in critically ill patients. 
Design and setting: A report outlining a process of literature review and recommendations from a consensus meeting conducted on behalf of the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG) in October 2011.
Results and conclusions: The consensus panel concluded that there are no adequately validated end points for Phase II trials in critically ill patients. However, the following were identified as potential Phase II end points: hospital-free days
to Day 90, ICU-free days to Day 28, ventilator-free days to Day 28, cardiovascular support-free days to Day 28, and renal replacement therapy-free days to Day 28. We
recommend that these end points be evaluated further.
Keyword Respiratory distress syndrome
Acute Lung Injury
Randomized Controlled Trials
Placebo controlled trial
Critically ill patients
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2013 Collection
School of Medicine Publications
 
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Created: Thu, 15 Nov 2012, 14:56:21 EST by System User on behalf of School of Medicine