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18.02.2020 | Conference Reports and Expert Panel

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

verfasst von: 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

Erschienen in: Intensive Care Medicine | Ausgabe 5/2020

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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.

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Titel: Contemporary strategies to improve clinical trial design for critical care research: insights from the First Critical Care Clinical Trialists Workshop
verfasst von: 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
Publikationsdatum: 18.02.2020
Verlag: Springer Berlin Heidelberg
Erschienen in: Intensive Care Medicine / Ausgabe 5/2020
Print ISSN: 0342-4642
Elektronische ISSN: 1432-1238
DOI: https://doi.org/10.1007/s00134-020-05934-6

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

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Live-Webinar: Aktuelle Leitlinien bei Herz-Kreislauf-Erkrankungen

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Abstract

Background

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