Editorial
doi: 10.1093/cid/ciaa853.
Understanding Early and Late Endpoints in Registrational Trials of Community-acquired Bacterial Pneumonia
Affiliations
- PMID: 32584958
- PMCID: PMC8563220
- DOI: 10.1093/cid/ciaa853
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Editorial
Understanding Early and Late Endpoints in Registrational Trials of Community-acquired Bacterial Pneumonia
Clin Infect Dis.
.
No abstract available
Keywords: US Food and Drug Administration (FDA); acute bacterial skin and skin structure infection (ABSSSI); clinical trial endpoints; community-acquired bacterial pneumonia (CABP); noninferiority trials.
Comment on
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Concordance of Early and Late End Points for Community-acquired Bacterial Pneumonia Trials.Clin Infect Dis. 2021 Nov 2;73(9):e2607-e2612. doi: 10.1093/cid/ciaa860. Clin Infect Dis. 2021. PMID: 32584969
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References
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- WikiQuote. Yogi Berra. Available at: https://en.wikiquote.org/wiki/Yogi_Berra. Accessed 6 June 2020.
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- US Food and Drug Administration. Guidance for industry: community-acquired bacterial pneumonia: developing drugs for treatment. Silver Spring, MD: Food and Drug Administration, 2014. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati.... Accessed 6 June 2020.
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- Talbot GH. The early clinical response endpoint: great timing by the food and drug administration? Clin Infect Dis 2017; 64:218–20. - PubMed
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- US Food and Drug Administration. Antibacterial drug products: use of noninferiority trials to support approval. Silver Spring, MD: Food and Drug Administration, 2010. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati.... Accessed 6 June 2020.
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