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by Dominic Tyer
Will explore how research and medicines development can be supported
The EMA has set up a big data taskforce to explore how the availability of large sets of information could be harnessed by medicines regulators.
In its sights are data from sources such as electronic health records, genomics, social media, clinical trials and spontaneous adverse reaction reports.
In particular its wants to look at how big data might support research, innovation and robust medicines development.
Over the next 18 months the taskforce will focus on mapping the sources and characteristics of big data and exploring its potential applicability and impact on medicines regulation.
It will also look at how legislation and guidelines may need to change and
create a big data roadmap for its use in the evaluation of marketing authorisation applications and clinical trials.
The EMA said in a statement: “The vast volume of data has the potential to contribute significantly to the way the benefits and risks of medicines are assessed over their entire lifecycle.”
The work is a joint project between the EMA and the heads of the national competent authorities in the European Economic Area (EEA), known as Heads of Medicines Agencies (HMA).
The new taskforce will be chaired Danish Medicines Agency the Lægemiddelstyrelsen and the EMA, and be made up of regulatory agency staff and some external big data advisors, who will join on an ad-hoc basis.
Opening that meeting the EMA’s executive director Guido Rasi said: “Big data enables us to generate a lot of conclusions; we have to be able to discriminate whether they represent causal relationships or spurious coincidence.”