The Guide on Methodological Standards in Pharmacoepidemiology offers a single web resource for methodological English language guidance in pharmacoepidemiology. For each topic covered, direct electronic access is given to internationally agreed recommendations, and key points from important guidelines, published articles and textbooks are highlighted. Where relevant, gaps in existing guidance are addressed with what ENCePP considers good practice.
The current version of the Guide is revision 8, dated July 2020.
The 8th revision of the Guide on Methodological Standards in Pharmacoepidemiology includes revisions, amendments and new references in most of the chapters. Revisions were performed by the authors in collaboration with the editorial group. External comments received were also considered.
For this 8th revision, a foreword highlights the importance of the Guide for pharmacoepidemiological studies carried-out in the context of the COVID-19 pandemic in order to provide valid results useful for clinicians and regulators. The foreword guides the reader to the chapters that may be particularly relevant for such studies.
The Guide is 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 may be forwarded to ENCePP_Secretariat@ema.europa.eu.
|Foreword to 8th Revision: ENCePP Guide supports strong observational research for the COVID‐19 pandemic|
|10. 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 pharmacovigilance impact research|