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

Current Opinion in Critical Care
George H Talbot

Abstract

Regulatory 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. The 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. Transatlantic 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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Citations

Oct 24, 2019·European Journal of Drug Metabolism and Pharmacokinetics·Awodayo O AdepitiAnthony A Elujoba
Jan 4, 2020·Analytical and Bioanalytical Chemistry·Linlin KongFei Yu
Apr 12, 2019·Clinical Pharmacokinetics·Carl AmilonBengt Hamrén
Feb 20, 2019·Critical Care : the Official Journal of the Critical Care Forum·Otavio T RanzaniAntoni Torres

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