Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Editorial
. 2021 Nov 2;73(9):e2613-e2615.
doi: 10.1093/cid/ciaa853.

Understanding Early and Late Endpoints in Registrational Trials of Community-acquired Bacterial Pneumonia

George H Talbot  1
Affiliations
Editorial

Understanding Early and Late Endpoints in Registrational Trials of Community-acquired Bacterial Pneumonia

George H Talbot. 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.

PubMed Disclaimer

Comment on

References

    1. WikiQuote. Yogi Berra. Available at: https://en.wikiquote.org/wiki/Yogi_Berra. Accessed 6 June 2020.
    1. 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.
    1. Bart SM, Nambiar S, Gopinath R, Rubin D, Farley JJ. Concordance of early and late endpoints for community-acquired bacterial pneumonia trials. Clin Infect Dis 2020:ciaa860. doi:10.1093/cid/ciaa860 - DOI - PubMed
    1. Talbot GH. The early clinical response endpoint: great timing by the food and drug administration? Clin Infect Dis 2017; 64:218–20. - PubMed
    1. 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.

MeSH terms