Improving clinical trials in the critically ill.

Objective: To propose ways in which clinical trials in intensive care can be improved.

Methods: An international roundtable conference was convened focused on improvement in three broad areas: translation of new knowledge from bench to bedside; design and conduct of clinical trials; and clinical trial infrastructure and environment.

Results: The roundtable recommendations were: improvement in clinical trials is a multistep process from better preclinical studies to better clinical trial methodology; new technologies should be used to improve models of critical illness; diseasomes and theragnostics will aid inpatient population selection and more appropriate targeting of interventions; broader study end points should include morbidity as well as mortality; more multicenter studies should be conducted by national and international networks or clinical trials groups; and better collaboration is needed with the industry.

Conclusions: There was broad agreement among the roundtable participants regarding a number of explicit opportunities for the improvement of clinical trials in critical care.