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 6, dated July 2017.
The 6th Revision of the Guide on Methodological Standards in Pharmacoepidemiology includes revisions, amendments and new references in all the chapters. Revisions were performed by the authors, in collaboration with the editorial group. External comments received were also considered.
Due to developments in some areas or need for restructuring and clarification, there have been more important changes in the following chapters:
3. Development of the study protocol
4.6. Research networks
5.2. Bias and confounding
5.6. Pragmatic trials and large simple trials
7. Quality management
9.2. Scientific integrity and ethical conduct
The following chapters were newly added:
4.3. Patient registries
Annex 1. to the Guide provides methodological guidance addressing the conduct of systematic reviews and meta-analyses of drug safety endpoints generated in completed (published or unpublished) comparative pharmacoepidemiological studies.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 email@example.com.
The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP®) is a network coordinated by the European Medicines Agency (EMA).