The advantages of involving artificial intelligence in signal detection
The role of risk-benefit assessment in the lifecycle of signal detection
Issues with definitions that need to be resolved: such as what is our definition of a signal?
The need to include clinical aspects in signal detection/ the need to always be mindful of how the drug is going to be used
The call was attended by 38 of the IWG’s 50 signal detection experts from the pharma industry, medicines regulators and academia including those from Australia and the US. Discussion also concerned the modus operandi of the IWG and short listing of the topics, each of which will be worked on by a subgroup of the IWG. Members of the IWG will meet remotely to define the science and issues around their given objective and propose ideas and guidance for improvement. These topics include:
use of big data, real world data and artificial intelligence in signal detection
linking multiple data sources to extend current signal detection methods
signal detection methods for biological products, advanced products and products with small usage
the relationship between the genotype and phenotype in terms of adverse drug reactions, signal detection, evaluation and management
The IWG on Signal Detection and Management in Pharmacovigilance is managed under the auspices of the DSRU Centre for Methods and Evidence in Pharmacovigilance (MEP), which was created in 2018 to undertake methodological work to improve and enhance pharmacovigilance.