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Perspective on Better Access to Data and Data Integration in Pharmacovigilance: Information from a Focus Group
Florence van Hunsel1,2, Samantha Lane3,4, Dawn Cooper3,4
1Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands. f.vanhunsel@lareb.nl.
Drug Safety
|January 14, 2026
Summary
Pharmacovigilance (PV) requires multimodal data analysis and diverse data source accessibility for robust drug safety surveillance. Challenges include data standardization, quality, and access, necessitating improved integration and rigor.
Area of Science:
- Pharmacovigilance
- Drug Safety
- Data Science
Background:
- Pharmacovigilance (PV) is crucial for monitoring drug safety post-market.
- Diverse data sources offer unique insights but present integration challenges.
- Current PV practices face hurdles in data standardization, quality, and accessibility.
Purpose of the Study:
- To discuss current challenges and opportunities in pharmacovigilance.
- To emphasize the need for a multimodal approach in data analysis and accessibility.
- To explore solutions for enhancing global drug safety monitoring.
Main Methods:
- A focus group discussion with nine participants with multisectoral expertise in PV.
- Exploration of various data types, including clinical trials and real-world data (RWD).
- Identification of challenges and emerging tools for pharmacovigilance.
Main Results:
- Key challenges identified: data standardization, quality variability, technological barriers, ethical concerns (social media data), and data access disparities.
- Emerging tools like knowledge graphs show potential for data integration and signal detection.
- Disparities in data access highlighted, including regulatory restrictions and limited infrastructure.
Conclusions:
- Improved integration, access, and methodological rigor are essential for strengthening PV practices.
- Fostering data transparency, secure sharing platforms, and collaborative consortia are proposed solutions.
- A multimodal approach is vital for effective global drug safety surveillance.
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