European Regulatory Bodies Look to Tackle Big Data

The European Medicines Agency (EMA) and the European Union’s Heads of Medicines Agencies have signed off on a new plan and taskforce with big ambitions to improve the integration of so-called “Big Data” into drug development and regulatory policy over the next several years.

EMA defines big data as “extremely large datasets that may be complex, multi-dimensional, unstructured, and heterogeneous.” Such datasets also “are accumulating rapidly, and…may be analyzed computationally 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 taskforce will engage with initiatives on the implementation of European Union regulations “to deliver data protection by design, engage with patients and healthcare professionals on data governance, and establish an Ethics Advisory Committee.”

Edited by Michael Causey