European drug agency sets out plans to publish clinical trial data from 2014BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e8423 (Published 12 December 2012) Cite this as: BMJ 2012;345:e8423
The European Medicines Agency has set out how it intends to ensure greater access to clinical trial data. The year long process will see the new policy in force from 1 January 2014 and reflects the agency’s move towards a more proactive publication policy.1
The final route map reflects input from experts across the European healthcare system and the drug industry at a workshop in London on 22 November. The agency’s director, Guido Rasi, made clear to participants the new policy of publishing clinical trial data once the marketing authorisation process is completed.
“Today represents the first step in delivering our vision. We are not here to decide if we will publish clinical trial data, only how. We need to do this in order to rebuild trust and confidence in the whole system,” he said at the outset of the meeting.
The agency is now implementing the first stage of its plan. It has invited nominations for members of its five advisory groups by 21 December. These will focus on protecting patients’ confidentiality, trial data formats, rules of engagement, good analysis practice, and legal aspects.
The groups will start meeting in early 2013 and produce their final advice by 30 April. Two months later the agency will open its draft policy to public consultation, which will run to the end of September. The final policy will be released on 30 November and take effect from 1 January 2014.
Input into the workshop from two senior European officials gave a clear indication of some of the issues that the advisory groups will have to consider. Gerhard Grill, the representative of the European ombudsman, who investigates complaints of maladministration by European Union bodies, set out the three main principles that should be followed.
He noted that the widest possible access should be given to documents and that any exceptions to that rule should be strictly interpreted and justified by adequate reasons. He called on the agency to ensure that in any of its decisions the relevant documents or data were not covered by any of the applicable exceptions when the public interest outweighed the interests of those seeking exceptions.
Giovanni Buttarelli, assistant to the independent European data protection supervisor, welcomed the new proactive approach but warned that compliance would depend on the purposes behind publishing the data and that it might be hard to ensure equal protection for all those whom the data concerned.
“Our position is that, as a rule, sensitive data about patients involved in trials cannot be disclosed, yet we recognise that identifying clinical investigators may be relevant in terms of conflict of interest. I would therefore encourage further discussion on modalities of publications,” he advised.
Cite this as: BMJ 2012;345:e8423