Guidelines for Good Database Selection and Use in Pharmacoepidemiology Research
These guidelines help researchers choose and use healthcare databases properly when studying how drugs are used and their effects in large populations. They offer practical advice to avoid common problems and ensure reliable results.
At a glance
Use when
Selecting or validating healthcare databases for observational drug safety or effectiveness studies; designing pharmacoepidemiological studies using secondary data
Avoid when
Conducting primary data collection studies or when working with non-healthcare databases unrelated to drug use or patient outcomes
Inputs
Healthcare databases, research objectives, study design parameters
Outputs
Recommendations for appropriate database use, checklist for quality assurance
How it works
Published in 2011, these guidelines provide structured recommendations for selecting and utilizing healthcare databases in pharmacoepidemiology research. They address study design challenges inherent to secondary data use, emphasizing procedures to ensure validity, privacy, and data quality. The document includes a checklist covering six domains: database selection, use of multiple data sources, study population extraction and analysis, privacy and security, quality and validation, and documentation.
- HTA domains
- Clinical Effectiveness, Safety, Organisational aspects
- Categories
- Context & ImplementationData GovernanceData Quality AssessmentReporting Standards & Best Practice
- Assumptions
- Databases are secondary data sources not originally collected for research; data quality and completeness vary across systems; researchers have access to technical and legal support for data handling
- Strengths
- Developed by experts in pharmacoepidemiology; includes practical checklist; addresses real-world limitations of database research; promotes methodological rigor and ethical standards
- Limitations
- May not cover newer data sources like real-world evidence platforms or EHRs beyond 2011; limited guidance on statistical methods specific to certain study designs
- Also known as
- Good Database Use Guidelines, ISPE Guidelines on Database Selection
Questions this answers
- › How should a healthcare database be selected for a pharmacoepidemiology study?
- › What are the key considerations when using multiple data sources?
- › How can data quality and validity be ensured in database research?
- › What privacy and security measures are necessary when handling health data?
- › How should study populations be defined and analyzed using database records?
- › What documentation practices support transparency and reproducibility?
References & sources
Similar by meaning
- ISPOR Retrospective Database Analysis Good Research Practices — Part III (Analytic Methods)
- ISPOR Good Research Practices for Retrospective Database Analysis Checklist (Part I)
- CODE-EHR best-practice framework
- ISPOR Prospective Observational Studies to Assess Comparative Effectiveness Good Research Practices Task Force Report
- D2.1 Whitepaper on the platform knowledge base and data standards for in silico drug repurposing
Beta record. Generated from the primary source via AI extraction and independent audit, pending final human review.