EMA opens consultation on the role of ‘big data’ for evaluation and supervision of medicines in the EU

As part of a report of the Heads of Medicines Agencies (HMA) – European Medicines Agency (EMA) Joint Big Data task force, recommendations and associated actions have been outlined for understanding the acceptability of evidence which is derived from ‘big data’ in support of the evaluation and supervision of medicines by regulators. Stakeholders are invited to submit feedback on the recommendations until 15th April 2019. Further focused work is required to understand the mechanisms by which the recommendations and actions may be achieved.

Large amounts of data are generated through adverse reaction reports, wearable devices, electronic health records, social media and clinical trials. Insights which are derived from this data will increasingly be used by regulators to assess the benefit-risk of medicines throughout their lifecycle, but first regulators require a greater understanding of the data landscape.

The definition of ‘big data’ which has been adopted by the task force is as follows: “extremely large datasets which may be complex, multi-dimensional, unstructured and heterogeneous, which are accumulating rapidly and which may be analysed computationally to reveal patterns, trends and associations. In general, big data sets require advanced or specialised methods to provide an answer within reliable constraints.”

When preparing the report, the HMA-EMA Joint Big Data task force assessed the generation of ‘big data’, the relevant sources and main formats, the methods for processing and analysing big data and the current state of expertise across the European medicines regulatory network. The task force considered six subgroups of data sources appropriate for regulatory decision making, which included genomics, bioanalytical ‘omics, observational data, social media and mobile health data, clinical trials and spontaneous adverse drug reactions data.

To read more about the role of big data for evaluation and supervision of medicines in the European Union, please click here.