International working group in pharmacovigilance launches new studies into 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. Best practice guidelines will be produced from the research.

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.