• Curr Opin Crit Care · Oct 2018

    Review

    Evolution and current status of United States Food and Drug Administration and European Medicines Agency regulatory guidance for studies of nosocomial pneumonia.

    • George H Talbot.
    • Talbot Advisors LLC, Anna Maria, Florida, USA.
    • Curr Opin Crit Care. 2018 Oct 1; 24 (5): 379-384.

    Purpose Of ReviewRegulatory guidance for design, conduct and analysis of studies of nosocomial pneumonia, including ventilator-associated pneumonia, has undergone substantial evolution over the past three decades. This review summarizes this evolutionary process and the current status of guidance.Recent FindingsThe US Food and Drug Administration and the European Medicines Agency have taken different approaches to defining endpoints for studies of nosocomial pneumonia, especially with regard to the primary endpoint. Both agencies accept a noninferiority design. Independent efforts to develop new endpoints and bridge existing discordances have been fruitful.SummaryTransatlantic differences in the approach to study of nosocomial pneumonia complicate study design and analysis, but they will hopefully be resolved in future iterations of regulatory agency guidance.

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