End points for Phase II trials in intensive care: recommendations from the Australian and New Zealand clinical trials group consensus panel meeting

Paul Young; Carol Hodgson; Joel Dulhunty; Manoj Saxena; Michael Bailey; Rinaldo Bellomo; Andrew Davies; Simon Finfer; Peter Kruger; Jeffrey Lipman; John Myburgh; Sandra Peake; Ian Seppelt; Stephen Streat; Rhiannon Tate; Steven Webb; ANZICS Clinical Trials Group

End points for Phase II trials in intensive care: recommendations from the Australian and New Zealand clinical trials group consensus panel meeting

Paul Young, Carol Hodgson, Joel Dulhunty, Manoj Saxena, Michael Bailey, Rinaldo Bellomo, Andrew Davies, Simon Finfer, Peter Kruger, Jeffrey Lipman, John Myburgh, Sandra Peake, Ian Seppelt, Stephen Streat, Rhiannon Tate, Steven Webb, ANZICS Clinical Trials Group

Research output: Contribution to journal › Article › peer-review

48 Citations (Scopus)

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.

Original language	English
Pages (from-to)	211-215
Number of pages	5
Journal	Critical Care and Resuscitation
Volume	14
Issue number	3
Publication status	Published - 2012
Externally published	Yes

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Young, P., Hodgson, C., Dulhunty, J., Saxena, M., Bailey, M., Bellomo, R., Davies, A., Finfer, S., Kruger, P., Lipman, J., Myburgh, J., Peake, S., Seppelt, I., Streat, S., Tate, R., Webb, S., & 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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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.",

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Young, P, Hodgson, C, Dulhunty, J, Saxena, M, Bailey, M, Bellomo, R, Davies, A, Finfer, S, Kruger, P, Lipman, J, Myburgh, J, Peake, S, Seppelt, I, Streat, S, Tate, R, Webb, S & 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, vol. 14, no. 3, pp. 211-215.

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T2 - recommendations from the Australian and New Zealand clinical trials group consensus panel meeting

AU - Young, Paul

AU - Hodgson, Carol

AU - Dulhunty, Joel

AU - Saxena, Manoj

AU - Bailey, Michael

AU - Bellomo, Rinaldo

AU - Davies, Andrew

AU - Finfer, Simon

AU - Kruger, Peter

AU - Lipman, Jeffrey

AU - Myburgh, John

AU - Peake, Sandra

AU - Seppelt, Ian

AU - Streat, Stephen

AU - Tate, Rhiannon

AU - Webb, Steven

AU - ANZICS Clinical Trials Group

PY - 2012

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AB - 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.

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End points for Phase II trials in intensive care: recommendations from the Australian and New Zealand clinical trials group consensus panel meeting

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