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International Working Group publishes first paper

The International Working Group (IWG) on New Developments in Pharmacovigilance has published its first paper this week. The paper details the IWG’s work in two areas in pharmacovigilance: case-level causality assessment and the strengths and limitations of data sources.

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.

Read the press release below or the full paper here.

Press release: International Working Group in Pharmacovigilance launches new studies causal inference and data sources

The International Working Group on New Developments in Pharmacovigilance (IWG), a consortium of international experts in pharmacovigilance, has launched two new studies to advance existing methodologies used in the detection, monitoring, and analysis of safety data in pharmacovigilance.

In a new paper published in Clinical Therapeutics, the group set out two new areas of focus: Causal Inference in Pharmacovigilance and Data Sources in Pharmacovigilance, their Strengths, and Uncertainties.

The IWG, which is coordinated by the Drug Safety Research Unit (DSRU) in the UK, has established two research groups for each area, which will now conduct methodological research to better understand each area and suggest improvements as appropriate.

Professor Robert Platt, of McGill University and Dr Miranda Davies, of the DSRU will lead the group assessing Causal Inference in Pharmacovigilance. Professor Platt said: “Novel therapeutics are continuously being developed to alleviate medical conditions, but with advancing technologies, there is a growing need to assess and improve methods of causality assessment.

“We will be conducting a comprehensive review, including a scoping review of scientific and grey literature, to produce a best practice document that addresses innovative causality assessment methodologies.”

Samantha Lane, of the DSRU, and Dr Florence van Hunsel, of Lareb in the Netherlands, will lead the group assessing data Sources in Pharmacovigilance. Samantha said: “Given the multitude of data sources in pharmacovigilance, we aim to create a guidance document that aids in the selection of the most appropriate data sources for specific pharmacovigilance activities. This initiative will contribute to the field by summarising the strengths, weaknesses, and risk of bias associated with each data source.”

The IWG was established in 2019 and comprises representatives from regulatory authorities, pharmaceutical companies, and academia across multiple countries and regions, including The Netherlands, France, New Zealand, Japan, Iraq, the US, Canada, and the UK. Members possess diverse expertise in clinical practice, biological science, epidemiology, and statistics, ensuring a comprehensive understanding of pharmacovigilance.

Notes to Editors

  1. DOI: https://doi.org/10.1016/j.clinthera.2023.12.008

The Drug Safety Research Unit is the UK’s leading pharmacovigilance and pharmacoepidemiology unit. For 40 years, the unit has conducted a broad range of pharmacoepidemiological studies, safety and drug utilisation studies and studies to support risk management and risk minimisation. In addition, the DSRU conducts studies and systematic reviews to understand the safety, use and risk-benefit balance of medicines and vaccines using real world data.