Identification, collection, and reporting of harms among non-industry-sponsored randomized clinical trials of pharmacologic interventions in the critically ill population: a systematic review.

Randomized trials of pharmacologic interventions conducted in critically ill populations and published in high impact journals often fail to adequately describe AE definitions, severity, attribution, and collection procedures. Among trials of similar interventions in comparable populations, variation in AE collection and reporting procedures is substantial. These factors may limit a clinician's ability to accurately balance the potential benefits and harms of an intervention.