10th Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology published

The 10^th annual Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology by the ENCePP Research Standards and Guidance working group has been published under EMA’s coordination. The 10^th Revision includes two new chapters on the use of artificial intelligence in pharmacoepidemiology (Chapter 15.5) and on real-world evidence and pharmacoepidemiology (15.6), and a new comprehensive Annex 2 on Methods for the evaluation of medicines in pregnancy and breastfeeding. Besides the updating of nearly all existing chapters, including considerations on methodological standards for COVID-19 studies, two chapters have been extensively revised: Comparative effectiveness research (15.1) and Vaccine research (15.2). Recommendations on the use of statistical significance for the interpretation of evidence have been added in the Overview of study designs (4.1). The Foreword from the co-chairs of the ENCePP Steering Group highlights the continued involvement of ENCePP in sound pharmacoepidemiological research, including into COVID-19, and real-world evidence studies. This 10^th Revision of the Guide provides a useful resource for researchers, regulators, marketing authorisation holders and applicants.

Related information: ENCePP Guide on Methodological Standards in Pharmacoepidemiology