TY - JOUR
T1 - End points for Phase II trials in intensive care
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
Y1 - 2012
N2 - 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.
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.
UR - http://www.scopus.com/inward/record.url?scp=84868244909&partnerID=8YFLogxK
M3 - Article
C2 - 22963216
AN - SCOPUS:84868244909
SN - 1441-2772
VL - 14
SP - 211
EP - 215
JO - Critical Care and Resuscitation
JF - Critical Care and Resuscitation
IS - 3
ER -