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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 9, dated July 2021.

 

The 9th Revision of the Guide includes extensive amendments, new references in most of the chapters, and an improved structure.

 

The Foreword highlights the importance of the Guide in the context of the COVID-19 pandemic and vaccination campaigns. Nearly all chapters contain relevant guidance on methodological standards to be used in COVID-19 studies, with references to selected publications illustrating relevant methodological aspects.

 

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(s) may be forwarded to ENCePP_Secretariat@ema.europa.eu.

Relevant documents:

 

Individual Chapters:

 

Foreword to ENCePP Guide Revision 9

1. Introduction

2. Formulating the research question and objectives

3. Development of the study protocol

4. Approaches to data collection

4.1. Primary data collection

4.2. Secondary use of data

4.3. Patient registries

4.4. Spontaneous reports

4.5. Social media

4.6. Research networks for multi-database studies

5. Study design

5.1. Overview

5.2. Types of study design

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

5.4. Specific aspects of study design

6. Methods to address bias and confounding

6.1. Bias

6.2. Confounding

6.3. Missing data

6.4. Triangulation

7. Effect measure modification and interaction

8. Systematic reviews and meta-analysis

9. Signal detection methodology application

9.1. General aspects of signal detection

9.2. Methods of statistical signal detection

9.3. Performance comparison of signal detection methods

9.4. Stratification and sub-group analyses

9.5. Masking

9.6. Complementary role of databases

10. The statistical analysis plan

10.1. General considerations

10.2. Timing of the statistical analysis plan

10.3. Elements of the statistical analysis plan

11. Quality management

11.1. General principles of quality management

11.2. Data quality frameworks

11.3. Quality management in clinical trials

11.4. Quality management in observational studies

12. Dissemination and communication of study results
13. Data protection and ethical aspects

13.1. Personal data protection in the European Union

13.2. Specific integrity and ethical conduct

14. Specific topics

14.1. Comparative effectiveness research

14.2. Vaccine safety and effectiveness

14.3. Design, implementation and analysis of pharmacogenomic studies

14.4. Methods for pharmacovigilance impact research

Annex 1. Guidance on conducting systematic revies and meta-analyses of completed comparative pharmacoepidemiological studies of safety outcomes