• Michael O Harhay, Jonathan D Casey, Marina Clement, Sean P Collins, Étienne Gayat, GongMichelle NgMNDivision of Critical Care Medicine, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA., Samir Jaber, Pierre-François Laterre, John C Marshall, Michael A Matthay, Rhonda E Monroe, Todd W Rice, Eileen Rubin, Wesley H Self, and Alexandre Mebazaa.
• Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, University of Pennsylvania, 304 Blockley Hall, 423 Guardian Drive, Philadelphia, PA, 19104-6021, USA. mharhay@pennmedicine.upenn.edu.
• Intensive Care Med. 2020 May 1; 46 (5): 930-942.

BackgroundConducting 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.MethodsIn 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.ConclusionThe 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 patient-informed outcome measures beyond mortality.

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