11th Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology published

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

The 11^th Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology has been published, in collaboration between EMA and the ENCePP Research Standards and Guidance Working Group.

The structure of the Guide has been revisited to better illustrate the evidence generation flow and to increase the emphasis on important methodology. Besides the update of several chapters, some have been revised to reflect a fast changing environment: Chapter 9 on Research networks for multi-database studies addresses the expansion and use of DARWIN EU®, and Chapters 16.1 on Comparative effectiveness research, 16.5 on Artificial intelligence, and 16.6 on Real-world evidence (RWE) and pharmacoepidemiology, have been extensively revised.

New recommendations, to foster transparency and high quality of non-interventional studies, and to facilitate their assessment, include the use of the causal inference target trial emulation approach and the estimand framework, and the use of the HARPER protocol template.

The Foreword from the co-chairs of the ENCePP Steering Group highlights the continued involvement of ENCePP in sound pharmacoepidemiological research, including drawing lessons from the COVID-19 pandemic and addressing new methodological challenges.

This 11^th Revision of the Guide continues to provide a useful resource for researchers, regulators, and marketing authorisation holders and applicants.