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About:
Contemporary strategies to improve clinical trial design for critical care research: insights from the First Critical Care Clinical Trialists Workshop
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research paper
schema:ScholarlyArticle
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Academic Article
research paper
schema:ScholarlyArticle
isDefinedBy
Covid-on-the-Web dataset
has title
Contemporary strategies to improve clinical trial design for critical care research: insights from the First Critical Care Clinical Trialists Workshop
Creator
Jaber, Samir
Marshall, John
Matthay, Michael
Gong, Michelle
Self, Wesley
Rice, Todd
Harhay, Michael
Laterre, Pierre-François
Mebazaa, Alexandre
Casey, Jonathan
Clement, Marina
Collins, Sean
Gayat, Étienne
Monroe, Rhonda
Rubin, Eileen
Source
PMC
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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s00134-020-05934-6) contains supplementary material, which is available to authorized users.
has issue date
2020-02-18
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bibo:doi
10.1007/s00134-020-05934-6
bibo:pmid
32072303
has license
no-cc
sha1sum (hex)
36b7f55f78139c22d9ef44100b002f1ec3e0027d
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https://doi.org/10.1007/s00134-020-05934-6
resource representing a document's title
Contemporary strategies to improve clinical trial design for critical care research: insights from the First Critical Care Clinical Trialists Workshop
has PubMed Central identifier
PMC7224097
has PubMed identifier
32072303
schema:publication
Intensive Care Med
resource representing a document's body
covid:36b7f55f78139c22d9ef44100b002f1ec3e0027d#body_text
is
schema:about
of
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