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Considerations for pharmacoepidemiological analyses in the SARS-CoV-2 pandemic

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DOI

  • Anton Pottegård, University of Southern Denmark
  • ,
  • Xavier Kurz, European Medicines Agency
  • ,
  • Nicholas Moore, University of Bordeaux
  • ,
  • Christian F Christiansen
  • Olaf Klungel, University of Southern Denmark, Utrecht University

The coronavirus disease 2019 (COVID-19) pandemic has triggered several hypotheses regarding use of specific medicines and risk of infection as well as prognosis. Under these unique circumstances, rapid answers require quick engagement in data collection and analyses, however, appropriate design and conduct of pharmacoepidemiologic studies is needed to generate valid and reliable evidence. In this paper, endorsed by the International Society for Pharmacoepidemiology, we provide methodological considerations for the conduct of pharmacoepidemiological studies in relation to the pandemic across eight domains: (1) timeliness of evidence, including the need to prioritize some questions over others in the acute phase of the pandemic; (2) the need to align observational and interventional research on efficacy; (3) the specific challenges related to 'real-time epidemiology' during an ongoing pandemic; (4) what design to use to answer a specific question; (5) considerations on the definition of exposures; (6) what covariates to collect; (7) considerations on the definition of outcomes; and (8) the need for transparent reporting. This article is protected by copyright. All rights reserved.

Original languageEnglish
JournalPharmacoepidemiology and Drug Safety
Volume29
Issue8
Pages (from-to)825-831
Number of pages7
ISSN1053-8569
DOIs
Publication statusPublished - Aug 2020

    Research areas

  • COVID-19, bias, methodology, pharmacoepidemiology

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