Contemporary strategies to improve clinical trial design for critical care research: insights from the First Critical Care Clinical Trialists Workshop

Michael O. Harhay, Jonathan D. Casey, Marina Clement, Sean P. Collins, Étienne Gayat, Michelle Ng Gong, Samir Jaber, Pierre François Laterre, John C. Marshall, Michael A. Matthay, Rhonda E. Monroe, Todd W. Rice, Eileen Rubin, Wesley H. Self, Alexandre Mebazaa

Research output: Contribution to journalArticle

1 Scopus citations

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 patient-informed outcome measures beyond mortality.

Original languageEnglish (US)
Pages (from-to)930-942
Number of pages13
JournalIntensive Care Medicine
Volume46
Issue number5
DOIs
StatePublished - May 1 2020

Keywords

  • Acute respiratory distress syndrome
  • Clinical trials
  • Critical care
  • Sepsis

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine

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    Harhay, M. O., Casey, J. D., Clement, M., Collins, S. P., Gayat, É., Gong, M. N., Jaber, S., Laterre, P. F., Marshall, J. C., Matthay, M. A., Monroe, R. E., Rice, T. W., Rubin, E., Self, W. H., & Mebazaa, A. (2020). Contemporary strategies to improve clinical trial design for critical care research: insights from the First Critical Care Clinical Trialists Workshop. Intensive Care Medicine, 46(5), 930-942. https://doi.org/10.1007/s00134-020-05934-6