The Guide on Methodological Standards in Pharmacoepidemiology offers a single online resource for methodological guidance in pharmacoepidemiology. For each topic covered, direct links to internationally agreed recommendations, key points from important guidelines, published articles and textbooks, are provided. Where relevant, gaps in existing guidance are addressed with what ENCePP considers good practice.
The current version of the Guide is Revision 10, dated 30 June 2022.
The 10th 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). Most of the chapters include new references. Revisions were performed by the co-authors in collaboration with the editorial group.
The Foreword from the co-chairs of the ENCePP Steering Group highlights the continued involvement of ENCePP in COVID-19 research and the disorders related to long COVID, and in real-world evidence studies. Nearly all chapters contain relevant guidance on methodological standards to be applied in COVID-19 studies, with references to selected publications illustrating relevant methodological aspects.
This version will continue supporting sound pharmacoepidemiological research and real-world evidence studies, and provides a useful resource for researchers, regulators, and marketing authorisation holders and applicants.
The Guide is maintained by the ENCePP Research Standards and Guidance working group under EMA’s coordination and updated annually by structured review to maintain its dynamic nature. It may also be amended as necessary in response to comments received. For this purpose, any comment and additional relevant guidance document(s) may be forwarded to ENCePP_Secretariat@ema.europa.eu.
|Foreword to ENCePP Guide Revision 10|
|4. Study design|
|5. Methods to address bias and confounding|
|6. Effect measure modification and interaction|
|9. Systematic reviews and meta-analysis|
|11. The statistical analysis plan|
|12. Quality management|
|13. Dissemination and communication of study results|
|14. Data protection and ethical aspects|
|15. Specific topics|
|Annex 1.||Guidance on conducting systematic revies and meta-analyses of completed comparative pharmacoepidemiological studies of safety outcomes|
|Annex 2.||Guidance on methods for the evaluation of medicines in pregnancy and breastfeeding|