Designing clinical trials in acute lung injury/acute respiratory distress syndrome.
OBJECTIVE
To review the implications of recent literature for clinical trial design in acute lung injury/acute respiratory distress syndrome (ARDS).


RESULTS
Refinement of acute lung injury/acute respiratory distress syndrome diagnostic criteria and study enrollment criteria, greater efforts to define usual care appropriately, and balancing of efficacy and effectiveness design principles will be key components of future trials.


CONCLUSIONS
Clinical trial design in acute lung injury/acute respiratory distress syndrome faces many challenges. Although we have learned much from past trials, persistent design dilemmas must be addressed for future trials.
Huang
David T
DT
The Clinical Research, Investigation, and Systems Modeling of Acute Illness Laboratory, Department of Critical Care Medicine, University of Pittsburgh, PA 15261, USA. huangdt@ccm.upmc.edu
Angus
Derek C
DC
D002986:Clinical Trials as Topic / Q000379:methods*; D003422:Critical Care; D006801:Humans; D018579:Patient Selection; D012107:Research Design; D012128:Respiratory Distress Syndrome / Q000628:therapy*; D016896:Treatment Outcome