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.