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Table 1 Summary of issues identified and proposed solutions

From: Perspective on optimizing clinical trials in critical care: how to puzzle out recurrent failures

Issues identified Potential consequences for the study 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