Table 1 Summary of issues identified and proposed solutions

Weakness of definitions of ICU diseases

Difficult to demonstrate trial and/or drug efficacy

Increase basic research, for example, on biomarkers

Current trial designs unadapted to ICU specificities

Lower impact of results and efficacy of trial

Adaptive design

Personalized medicine

80 % of patients recruited by 20 % of sites

Possible bias, center effect

Improved site selection

Overestimation of recruitment capacity

Recruitment objectives not met, study closed

More precise calculation of recruitment capacity

Evaluation of prior performance

Competing trials not considered during feasibility

Patients eligible for several studies

Tracking tables of all studies even potential

Caregivers not involved in research

Possible bias due to lack of information

Involvement of every member of the unit

Numerous players

Confusion, delay or lack of information

Standard operating procedures with different units

Regular meetings

Under recruitment

Study closed for lack of patients

Research team available 24/7

Systematic screening procedures

Clinical coordinating center

Complex and tight schedule of events

Missing data, delay

Computerized medical records

Automatic alerts for results or treatment

Long-term follow-up of patients

Many patients lost to follow-up

Tracking tables with reminders

Lack of training for physicians

Physicians do not feel involved

Training included as soon as medical studies

Specific training courses

Lack of involvement of investigators in pharmaceutical-sponsored trials

Design unadapted to ICU research

Investigators do no feel involved

Involvement of physicians since the beginning of the process

Clinical research still considered as a stand-alone activity

Cares and treatments competing with routine

Clinical research implemented as part of routine care