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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 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.

Relevant documents:

 

Individual Chapters:

 

Foreword to 8th Revision: ENCePP Guide supports strong observational research for the COVID‐19 pandemic

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 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 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