Abstract
The evolution of scientific investigation in acute lung injury (ALI) and acute respiratory
distress syndrome (ARDS) is replete with examples of effective bench-to-bedside transitions,
pioneering research methodology, and international collaboration. This article highlights
for clinicians a selection of challenges and controversies of clinical trial design
in ALI and ARDS. A section on Patient Selection highlights controversial trade-offs
between homogeneous and heterogeneous study populations. A section on Clinical Protocols
covers blinding, process-of-care interventions, usual-care control groups, and standardized
protocols for adjunctive care. The third section discusses the quest for ideal Study
Outcomes. The final section presents Interpretation Controversies, such as early stopping
of clinical trials.
Keywords
acute lung injury - acute respiratory distress syndrome - clinical trial designs -
research methodology - patient selection
