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ENCePP Guide on Methodological Standards in Pharmacoepidemiology


Foreword to ENCePP Guide revision 9

The COVID-19 pandemic and vaccination campaign have a profound impact on the practice of pharmacoepidemiology. The urgent need for data gives high visibility to researchers but also generates high expectations for the rapid conduct of studies and publication of results. The research community has raised to the challenge: it developed new collaborative networks, created large cohorts of patients and obtained fast access to electronic health care records linked to other health data such as vaccination registries, hospital records and laboratory data.


Many studies apply existing designs to new questions, providing an important source of learning on the correct and incorrect use of epidemiological methods. It was not possible for ENCePP to review this large body of evidence published in many different scientific journals or posted before a peer-review. A specific chapter of the ENCePP Guide dedicated to such studies would certainly miss important ones and become rapidly outdated. The decision was therefore to not include such chapter in this revision, despite the public health importance of the topic.


ENCePP rather considered that nearly all chapters of the Guide already contain relevant guidance on the methodological standards to be used in COVID-19 studies. Hence, the choice was made to augment many chapters of the Guide with a presentation of carefully selected studies illustrating pertinent methodological aspects. Researchers interested in methods applicable to COVID-19 research should first read the relevant chapter and then consult the discussion of these studies.


ENCePP is confident that this 9th revision of the ENCePP Guide will contribute to the use of appropriate methods in COVID-19 research, to the conduct of valid and reliable studies on the effectiveness and safety of treatments and vaccines and, ultimately, to the effective management of the COVID-19 pandemic.


Susana Perez-Gutthann,

Gianmario Candore

Co-Chairs of the ENCePP Steering Group



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