The European Medicines Agency (EMA) and the heads of the Medicines Authorities of the European Union have signed a new plan and a task force with great ambitions to improve the integration of so-called “big data” into drug development and regulatory policy over the next few years.
The EMA defines big data as “extremely large data sets that can be complex, multi-dimensional, unstructured and heterogeneous”. Such data sets “accumulate quickly and can be computationally analyzed to reveal patterns, trends and associations”.
Big data sources include clinical trial results, adverse drug reaction reports, and forms of real world data, including data from patient registries and wearable devices.
Among its many priorities, the new task force will address initiatives to implement European Union rules “to ensure data protection through design, work with patients and healthcare professionals on data governance and establish an ethics committee”.
Modifications made by Michael Causey