Perspective on optimizing clinical trials in critical care: how to puzzle out recurrent failures.
BACKGROUND
Critical care is a complex field of medicine, especially because of its diversity and unpredictability. Mortality rates of the diseases are usually high and patients are critically ill, admitted in emergency, and often have several overlapping diseases. This makes research in critical care also complex because of patients' conditions and because of the numerous ethical and regulatory requirements and increasing global competition. Many clinical trials in critical care have thus failed and almost no drug has yet been developed to treat intensive care unit (ICU) patients. Learning from the failures, clinical trials must now be optimized.


METHODS
Several aspects can be improved, beginning with the design of studies that should take into account patients' diversity in the ICU. At the site level, selection should reflect more accurately the potential of recruitment. Management of all players that can be involved in the research at a site level should be a priority. Moreover, training should be offered to all staff members, including the youngest. National and international networks are also part of the future as they create a collective synergy potentially improving the efficacy of sites. Finally, computerization is another area that must be further developed with the appropriate tools.


CONCLUSIONS
Clinical research in the ICU is thus a discipline in its own right that still requires tailored approaches. Changes have to be initiated by the investigators themselves as they know all the specificities of the field.
Medical-surgical Intensive Care Unit, Dupuytren University Hospital, 2 avenue Martin Luther King, 87042 Limoges, France ; Inserm CIC 1435, Limoges University Hospital, Limoges, France.
Bruno
0000-0002-2531-1652
B
François
Medical-surgical Intensive Care Unit, Dupuytren University Hospital, 2 avenue Martin Luther King, 87042 Limoges, France.
Marc
M
Clavel
Medical-surgical Intensive Care Unit, Dupuytren University Hospital, 2 avenue Martin Luther King, 87042 Limoges, France.
Philippe
P
Vignon
Medical-surgical Intensive Care Unit, Cliniques Saint-Luc, Brussels, Belgium.
Pierre-François
PF
Laterre
Clinical research; Intensive care unit; Investigation center; Performance; Trials; Ventilator-associated pneumonia