The clinical research enterprise in critical care: What's right, what's wrong, and what's ahead?

Abstract

Intensivists have been remarkably successful in using randomized controlled trials to assess aspects of current practice. Unfortunately, this success has not been mirrored in trials of new pharmacotherapy, despite convincing pathophysiological rationales and encouraging preliminary studies. Misunderstandings of biological processes and flawed early clinical studies have led to the almost universal failure of fundamentally new treatments subjected to large phase III trials, despite their sound methodology. Compounding these problems is the tendency for new approaches to be either implemented widely on the basis of relatively poor studies or ignored despite strong supporting evidence. Having m..