CONSENSUS-ASSISTED DEVELOPMENT OF A STUDY PROTOCOL ON SEPSIS - AN IMPORTANT DIFFERENCE FROM PREVIOUS RANDOMIZED TRIALS - DISCUSSION

The study protocol of a multicentre, randomised, double-blind, control led clinical trial on sepsis was analysed by a panel of experts who ha ve contributed critical articles in a discussion forum. This procedure raised the question whether doctors would ever spontaneously agree to a study design so complex. A process of consensus is proposed in this article which could create protocols for sepsis trials much less open to criticism. The quick and never-ending production of antagonists in this field makes it almost mandatory to develop such a consensus-assi sted procedure. The consensus in future trials might reduce the high f racture rate of studies, especially with cytokine-anticytokine therapy .