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ENCePP Guide on Methodological Standards in Pharmacoepidemiology

Section 7.1. Principles of communication

Aspects of research communication and reporting include, but are not limited to, reports to health authorities, sponsors, presentations in scientific fora, scientific publications, patient focused communications and websites.

The Declaration of Helsinki provides guidance on the registration, publication and dissemination of research results. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject. A means to achieve this with pharmacoepidemiology studies is through registration of protocols and reports of studies in the EU PAS Register.

Individual Chapters:

1. General aspects of study protocol
2. Research question
3. Approaches to data collection
3.1. Primary data collection
3.2. Secondary use of data
3.3. Research networks
3.4. Spontaneous report database
3.5. Using data from social media and electronic devices as a data source
3.5.1. General considerations
4. Study design and methods
4.1. General considerations
4.2. Challenges and lessons learned
4.2.1. Definition and validation of drug exposure, outcomes and covariates
4.2.1.1. Assessment of exposure
4.2.1.2. Assessment of outcomes
4.2.1.3. Assessment of covariates
4.2.1.4. Validation
4.2.2. Bias and confounding
4.2.2.1. Choice of exposure risk windows
4.2.2.2. Time-related bias
4.2.2.2.1. Immortal time bias
4.2.2.2.2. Other forms of time-related bias
4.2.2.3. Confounding by indication
4.2.2.4. Protopathic bias
4.2.2.5. Surveillance bias
4.2.2.6. Unmeasured confounding
4.2.3. Methods to handle bias and confounding
4.2.3.1. New-user designs
4.2.3.2. Case-only designs
4.2.3.3. Disease risk scores
4.2.3.4. Propensity scores
4.2.3.5. Instrumental variables
4.2.3.6. Prior event rate ratios
4.2.3.7. Handling time-dependent confounding in the analysis
4.2.4. Effect modification
4.3. Ecological analyses and case-population studies
4.4. Hybrid studies
4.4.1. Pragmatic trials
4.4.2. Large simple trials
4.4.3. Randomised database studies
4.5. Systematic review and meta-analysis
4.6. Signal detection methodology and application
5. The statistical analysis plan
5.1. General considerations
5.2. Statistical plan
5.3. Handling of missing data
6. Quality management
7. Communication
7.1. Principles of communication
7.2. Guidelines on communication of studies
8. Legal context
8.1. Ethical conduct, patient and data protection
8.2. Pharmacovigilance legislation
8.3. Reporting of adverse events/reactions
9. Specific topics
9.1. Comparative effectiveness research
9.1.1. Introduction
9.1.2. General aspects
9.1.3. Prominent issues in CER
9.1.3.1. Randomised clinical trials vs. observational studies
9.1.3.2. Use of electronic healthcare databases
9.1.3.3. Bias and confounding in observational CER
9.2. Vaccine safety and effectiveness
9.2.1. Vaccine safety
9.2.1.1. General aspects
9.2.1.2. Signal detection
9.2.1.3. Signal refinement
9.2.1.4. Hypothesis testing studies
9.2.1.5. Meta-analyses
9.2.1.6. Studies on vaccine safety in special populations
9.2.2. Vaccine effectiveness
9.2.2.1. Definitions
9.2.2.2. Traditional cohort and case-control studies
9.2.2.3. Screening method
9.2.2.4. Indirect cohort (Broome) method
9.2.2.5. Density case-control design
9.2.2.6. Test negative design
9.2.2.7. Case coverage design
9.2.2.8. Impact assessment
9.2.2.9. Methods to study waning immunity
9.3. Design and analysis of pharmacogenetic studies
9.3.1. Introduction
9.3.2. Identification of genetic variants
9.3.3. Study designs
9.3.4. Data collection
9.3.5. Data analysis
9.3.6. Reporting
9.3.7. Clinical practice guidelines
9.3.8. Resources
Annex 1.	Guidance on conducting systematic revies and meta-analyses of completed comparative pharmacoepidemiological studies of safety outcomes

Resources Database

Partners forum

EU PAS Register