EMA Highlights: Research data sharing to be ‘user friendly’

by Gary Finnegan – The EU medicines regulator has rejigged its plan on how clinical trial data will be shared with health professionals, after intense lobbying by doctors, hospital pharmacists and the European Ombudsman.

The EMA said it would make it easier for academics and health professionals to use clinical trial information and research results by making it possible to download, save and print data.

Guido Rasi, who heads up the London-based EU regulator, said the Agency would proactively publish clinical trial data submitted as part of marketing authorisation applications and make it easier to use for academic and non-commercial purposes.

This reverses an earlier plan which restricted researchers to view a ‘read only’ version of the database on their computer screen without having the option to download it.

The new policy comes into force in October and follows more than a year of consultation and debate about how to achieve responsible data sharing.

Transparency advocates want publication of clinical trial information and supporting documents submitted to the EMA while research-based pharmaceutical companies have raised concern about commercial sensitivity and data privacy.