EMA unveils trial data

Last Friday, the European Medicines Agency (EMA) announced it would start giving open access to clinical reports for new medicines for human use authorised in the EU. It is the first regulator worldwide to take this step. 

The publication of the trial data follows the adoption of a policy on the publication of clinical data for human medicines, which came into force at the beginning of 2015. The London-based agency already published data for the two medicines Kyprolis (carfilzomib) and Zurampic (lesinurad), amounting to around 260,000 pages of information for over 100 clinical reports. Bit by bit, more data will be added for all applications since the policy was adopted. 

“Transparency is an essential component in clinical research,” commented Vytenis Andriukaitis, European Commissioner for Health and Food Safety. “EMA’s transparency initiative will make Europe a true front runner with respect to release of data concerning clinical trials. It will create a bridge from now until the new Clinical Trials Regulation – which foresees additional milestones towards transparency, becomes applicable.”

EMA’s Executive Director Guido Rasi added: “Our initiative has shaped the global debate towards more transparency. It will benefit academic research and the practice of medicine as a whole.”

Associations have welcomed the initiative. “Greater access to trial data in the long term is a good thing for R&D. It helps researchers to learn from both positive and negative outcomes in trials and ensures that clinical data is not lost and research doomed to be repeated from a lack of knowledge in the future,” said Claire Skentelbery, Secretary General of the European Biotechnology Network, and went on to sound a not of caution:  “These must always be taken with caution however, given the immense complexity of trial parameters and the ease with which misleading headlines and messages to patients can be created from incomplete understanding.”

European pharma association EFPIA stated: “EFPIA has been taking an involved part in the stakeholder discussions arranged by EMA. We believe the key to successful implementation is the continuous review of experience and requirements and we look forward to engaging with the Agency on this topic.”