Abstract
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 are 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 prioritise 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.
Original language | English |
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Pages (from-to) | 825-831 |
Number of pages | 7 |
Journal | Pharmacoepidemiology and Drug Safety |
Volume | 29 |
Issue number | 8 |
DOIs | |
Publication status | Published - 1 Aug 2020 |
Funding
The authors are grateful to Peter Arlett, Marco Cavaleri, and Hans-Georg Eichler (The European Medicines Agency), Henrik Toft S?rensen (Aarhus University), Jesper Hallas, Kasper B. Kristensen and Mette Reilev (University of Southern Denmark) and Almut Winterstein, Krista Huybrechts and Alison Bourke (The International Society for Pharmacoepidemiology) for valuable input to the manuscript.
Keywords
- bias
- COVID-19
- methodology
- pharmacoepidemiology