Contemporary strategies to improve clinical trial design for critical care research: insights from the First Critical Care Clinical Trialists Workshop.
2020
Abstract
Background: Conducting research in critically-ill patient populations is challenging, and most randomized trials of
critically-ill patients have not achieved pre-specified statistical thresholds to conclude that the intervention being
investigated was beneficial.
Methods: In 2019, a diverse group of patient representatives, regulators from the USA and European Union, federal
grant managers, industry representatives, clinical trialists, epidemiologists, and clinicians convened the First Critical
Care Clinical Trialists (3CT) Workshop to discuss challenges and opportunities in conducting and assessing critical
care trials. Herein, we present the advantages and disadvantages of available methodologies for clinical trial design,
conduct, and analysis, and a series of recommendations to potentially improve future trials in critical care.
Conclusion: The 3CT Workshop participants identified opportunities to improve critical care trials using strategies
to optimize sample size calculations, account for patient and disease heterogeneity, increase the efficiency of trial
conduct, maximize the use of trial data, and to refine and standardize the collection of patient-centered and patientinformed
outcome measures beyond mortality.
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