Interplay of Spontaneous Reporting and Longitudinal Healthcare Databases for Signal Management: Position Statement from the Real-World Evidence and Big Data Special Interest Group of the International Society of Pharmacovigilance
Signal management, defined as the set of activities from signal detection to recommendations for action, is conducted using different data sources and leveraging data from spontaneous reporting databases (SRDs), which represent the cornerstone of pharmacovigilance. However, the exponentially increasing generation and availability of real-world data collected in longitudinal healthcare databases (LHDs), along with the rapid evolution of artificial intelligence-based algorithms and other advanced analytical methods, offers a wide range of opportunities to complement SRDs throughout all stages of signal management, especially signal detection. Integrating information derived from SRDs and LHDs may reduce their respective limitations, thus potentially enhancing post-marketing surveillance. The aim of this position statement is to critically evaluate the complementary role of SRDs and LHDs in signal management, exploring the potential benefits and challenges in integrating information coming from these two data sources. Furthermore, we presented successful cases of the interplay between SRDs and LHDs for signal management, along with future opportunities and directions to improve such interplay.
Authors
- Andrew Bate (ORCID: https://orcid.org/0000-0003-3151-3653)
- Saad Shakir (ORCID: https://orcid.org/0000-0002-4084-297X)
- Alexandre Pariente (ORCID: https://orcid.org/0000-0002-7873-5483)
- G. Niklas Norén (ORCID: https://orcid.org/0000-0002-4595-230X)
- Gianmario Candore (ORCID: https://orcid.org/0000-0002-7299-7300)
- Mulugeta Russom (ORCID: https://orcid.org/0000-0003-1939-5842)
- Jackie Brown
- Tarek A. Hammad (ORCID: https://orcid.org/0000-0001-8229-4716)
- Marco Tuccori (ORCID: https://orcid.org/0000-0002-7979-8486)
- Andrej Segec (ORCID: https://orcid.org/0000-0003-2881-0593)
- Gianluca Trifirò (ORCID: https://orcid.org/0000-0003-1147-7296)
- Judith C. Maro (ORCID: https://orcid.org/0000-0001-9900-2142)
- Eugène van Puijenbroek (ORCID: https://orcid.org/0000-0002-2236-1398)
- Rebecca E. Chandler (ORCID: https://orcid.org/0000-0002-9334-9046)
- Andrea Spini (ORCID: https://orcid.org/0000-0001-7496-5575)
- Samantha Lane (ORCID: https://orcid.org/0000-0001-7532-1149)
- Maribel Salas (ORCID: https://orcid.org/0000-0001-5634-1558)
- Sengwee Toh
- Salvatore Crisafulli
Institutions
- Uppsala Monitoring Centre (SE)
- University of Verona (IT)
- European Medicines Agency (NL)
- Harvard University (US)
- Bayer (United States) (US)
- Université de Bordeaux (FR)
- Inserm (FR)
- University of Groningen (NL)
- Erasmus MC (NL)
- Centre Hospitalier Universitaire de Bordeaux (FR)
- London School of Hygiene & Tropical Medicine (GB)
- Bordeaux Population Health (FR)
- Coalition for Epidemic Preparedness Innovations (NO)
- Netherlands Pharmacovigilance Centre Lareb (NL)
- Takeda (United States) (US)
- Drug Safety Research Unit (GB)
- TriNetX (United States) (US)
- University of Portsmouth (GB)
- Bayer (Germany) (DE)
- University of Pennsylvania (US)
- University of Asmara (ER)
Publication Details
- Journal
- Drug Safety
- Published
- 2025-04-13
- DOI
- https://doi.org/10.1007/s40264-025-01548-3
- Citations
- 15
- Primary Topic
- Pharmacovigilance and Adverse Drug Reactions
- Type
- article
- Field-Weighted Citation Impact
- 19.61
Funders
- Università degli Studi di Verona