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.
Angus
Derek C
DC
CRISMA Laboratory, Department of Critical Care Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Mira
Jean-Paul
JP
Vincent
Jean-Louis
JL
D026683:Advisory Committees; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D003422:Critical Care / Q000379:methods / Q000592:standards; D016638:Critical Illness / Q000628:therapy; D006801:Humans; D008433:Mathematics; D015337:Multicenter Studies as Topic; D018579:Patient Selection; D055818:Public-Private Sector Partnerships; D012107:Research Design; D057170:Translational Research, Biomedical