Aetion | ENCePP - Methodological Standards in Pharmacoepidemiology

On July 1, 2022, the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENcEPP) published an update to their Guide on Methodological Standards in Pharmacoepidemiology (Revision 10) under the coordination of the European Medicines Agency (EMA).  

This guide, Revision 10, provides a comprehensive overview of available pharmacoepidemiology methods and key considerations for their use based on published articles and texts, as well as other sources. 

Highlights from Revision 10:

• A new chapter on artificial intelligence 
• A new chapter on real-world evidence (RWE) and pharmacoepidemiology
• A new annex on evaluation of medicines in pregnancy and breastfeeding
• Updates to nearly all existing chapters, including extensive revisions to the comparative effectiveness research and vaccine research chapters, as well as recommendations on the use of statistical significance for the interpretation of evidence within the study designs chapter

Additionally, Revision 10 features newly published references supporting RWE study design and data feasibility assessment that were authored by current Aetion leaders: 

• A Structured Preapproval and Postapproval Comparative Study Design Framework to Generate Valid and Transparent Real-World Evidence for Regulatory Decisions
• The Structured Process to Identify Fit-For-Purpose Data: A Data Feasibility Assessment Framework
• ​​Graphical Depiction of Longitudinal Study Designs in Healthcare Databases
• Empirical Assessment of Case-based Methods for Identification of Drugs Associated with Acute Liver Injury in the French National Healthcare System Database (SNDS)
• The Role of Real-World Evidence in FDA-Approved New Drug and Biologics License Applications

Aetion applauds the continued efforts of ENCePP to ensure their methods guide is comprehensive, reflective of current knowledge, and aimed at junior and seasoned researchers alike. Revision 10 is an important complement to worldwide regulatory guidance on the design and conduct of RWE studies.

Contact us to learn more about Revision 10 or to engage directly with one of our pharmacoepidemiology experts.