Evidence map›Paper›PMID 41533330›Full record

ArticleDrug safety2026

Perspective on Better Access to Data and Data Integration in Pharmacovigilance: Information from a Focus Group.

Florence van Hunsel, Samantha Lane, Dawn Cooper, Taylor Aurelius, Amy Bobbins, Harriet Dickinson, Manfred Hauben, Denise Morris, Eugene van Puijenbroek, Alison Yeomans and 2 more

Abstract read
In one paragraph

Article in Drug safety, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Florence van HunselNetherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands. f.vanhunsel@lareb.nl.ORCID http://orcid.org/0000-0001-8965-3224
Samantha LaneCentre for Pharmacovigilance Sciences, Drug Safety Research Unit, Southampton, UK.ORCID http://orcid.org/0000-0001-7532-1149
Dawn CooperCentre for Pharmacovigilance Sciences, Drug Safety Research Unit, Southampton, UK.
Taylor AureliusCentre for Pharmacovigilance Sciences, Drug Safety Research Unit, Southampton, UK.
Amy BobbinsCentre for Pharmacovigilance Sciences, Drug Safety Research Unit, Southampton, UK.
Harriet DickinsonRWE, Gilead Sciences, Uxbridge, UK.
Manfred HaubenMerck KGaA, New York City, USA.
Denise MorrisCentre for Pharmacovigilance Sciences, Drug Safety Research Unit, Southampton, UK.
Eugene van PuijenbroekNetherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands.
Alison YeomansCentre for Pharmacovigilance Sciences, Drug Safety Research Unit, Southampton, UK.
Manal YounusIraqi Pharmacovigilance Centre, Ministry of Health, Baghdad, Iraq.
Saad ShakirCentre for Pharmacovigilance Sciences, Drug Safety Research Unit, Southampton, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A focus group organised by the Drug Safety Research Unit (DSRU) International Working Group (IWG) on New Developments in Pharmacovigilance discussed current challenges and opportunities in pharmacovigilance (PV), emphasising the need for a multimodal approach in data analysis and accessibility of diverse data sources for drug safety surveillance. Nine participants, selected purposefully for their multisectoral expertise in PV, discussed the value of various data types, including data from clinical trials and real-world data (RWD), each offering distinct strengths and limitations. Key challenges identified included data standardisation, quality variability, technological barriers and ethical concerns, particularly with data derived from social media. Emerging tools such as knowledge graphs were highlighted for their potential to enhance data integration and signal detection, however further research is required. The group also addressed disparities in data access, with particular attention to regulatory restrictions, limited infrastructure in low-resource settings and restricted access to industry-held data. Proposed solutions included fostering greater data transparency, establishing secure data-sharing platforms and forming collaborative consortia to facilitate responsible and ethical data use. Overall, the discussion underscored the need for improved integration, access and methodological rigour to strengthen PV practices and enhance global drug safety monitoring.

Indexed as

PharmacovigilanceAccess to InformationAdultAdverse Drug Reaction Reporting SystemsAgedConsumer Product SafetyDrug-Related Side Effects and Adverse ReactionsFemaleFocus GroupsHumansInformation DisseminationMaleMiddle Aged

Identifiers

PMID41533330
PMCPMC13161301

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.