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International Working Group makes progress with causality and data sources

The International Working Group (IWG) on New Developments in Pharmacovigilance has been working hard throughout 2023. The IWG brings together around 70 experts from across the world and is working in specific areas where there is scope to advance pharmacovigilance and pharmacoepidemiology methods.

The IWG meets regularly and has made significant progress on both of its current topics. The group recently held its online autumn plenary meeting, at which the co-chairs for each topic provided updates on recent achievements.

Topic 1 Causal inference in Pharmacovigilance (Chaired by Dr Miranda Davies, DSRU, and Prof Robert Platt, McGill University)

For the first topic, the working group is conducting a review of causal inference in pharmacovigilance, and will produce a scoping review. Part 1 will be a best practice document which assesses existing methods of case-level causality assessment and considers their strengths and weaknesses. Part 2 will focus on use of innovative methods, such as artificial intelligence and machine learning, in assigning causality.

Topic 2: Data sources in Pharmacovigilance: their strengths and uncertainties (Chaired by Samantha Lane, DSRU, and Dr Florence van Hunsel, Lareb)

For the second topic, the IWG is looking into the data sources that are available for pharmacovigilance. The group will conduct a scoping review and ultimately aims to publish easily accessible guidance which summarises the most appropriate data sources to answer specific questions in pharmacovigilance.

Protocols for each of the reviews are currently being finalised and the group plans to start searches before the end of 2023.

An article detailing the objectives and work of the IWG has been accepted by the journal Clinical Therapeutics and will be published in early 2024.

The ultimate aim of the IWG is to protect patients from the hazards of medicines and facilitate the safe and effective use of medicines and vaccines. Members are drawn from a range of pharmaceutical companies, academia and medicines regulators, including Lilly, Novartis, Roche, GlaxoSmithKline, Bayer, the MHRA, the FDA, Harvard University, University of Portsmouth, University of Southern Denmark, and Oslo Metropolitan University.

See the IWG webpage for more information.

December 2023