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Home > Standards & Guidances > Methodological Guide

ENCePP Guide on Methodological Standards in Pharmacoepidemiology

 

 

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 7, dated July 2018.

 

The 7th 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, the ENCePP Guide has been more significantly revised in the following chapters:

  • 4.3. Patient registries
  • 4.5. Social media and electronic devices
  • 4.6. Research networks
  • 5.1. Definition and validation of drug exposure, outcomes and covariates
  • 5.3. Methods to address bias
  • 5.9 Methods for pharmacovigilance impact research

Chapter 5.9 is complemented by Annex 2 which provides more detailed guidance on methods for pharmacovigilance impact research developed by an ENCePP Special Interest Group.

 

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_comments@ema.europa.eu.

Relevant documents:

 

Individual Chapters:

 

1. Introduction

2. Formulating the research question

3. Development of the study protocol

4. Approaches to data collection

4.1. Primary data collection

4.2. Secondary data collection

4.3. Patient registries

4.4. Spontaneous reports

4.5. Social media

4.6. Research networks

5. Study design and methods

5.1. Definition and validation of drug exposure, outcomes and covariates

5.2. Bias (systematic error)

5.3. Methods to address bias

5.4. Effect measure modification and interaction

5.5. Ecological analyses and case-population studies

5.6. Pragmatic trials and large simple trials

5.7. Systematic reviews and meta-analysis

5.8. Signal detection methodology and application

5.9. Methods for pharmacovigilance impact research

6. The statistical analysis plan

6.1. General considerations

6.2. Timing of the statistical analysis plan

6.3. Decision criteria

6.4. Statistical analysis plan structure

6.5. Handling of missing data

7. Quality management

8. Dissemination and communication of study results

9. Data protection and ethical aspects

9.1. Patient and data protection

9.2. Scientific integrity and ethical conduct

10. Specific topics

10.1. Comparative effectiveness research

10.2. Vaccine safety and effectiveness

10.3. Design and analysis of pharmacogenetic studies

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