Abstract
Many studies have been conducted to try and find interventions to treat patients with severe sepsis, but with little success. In several cases, initial apparent beneficial effects have not been confirmed in later trials. The story of steroids in sepsis is one example of this pendulum effect, with initial success in the study by Annane et al. tempered by the more recent negative results of the Corticus study. The reasons for this pendulum effect are likely related, at least in part, to issues of clinical trial design and the way in which clinical trials in intensive care unit patients are developed, conducted and assessed needs to be critically reassessed.