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EMA intend to publish clinical trials reports

The European Medicines Agency (EMA) has agreed in principle to publish clinical-trials reports on any drug that receives marketing approval in the European Union - and to do so proactively, without the need for formal freedom-of-information request. The EMA is the first major drug regulatory agency to take such a step, which it sees as a significant move towards increasing transparency in the processes involved in approving medicines. The agency made its announcement in a statement on 12 June. It said that it will publish the details of the new policy in mid-July, and that the policy will become effective on 1 October.

The policy will make it easier for academics to carry out research for non-commercial purposes - for example, to reanalyse data from a clinical trial or compare data from different trials to work out the best treatment for a particular disease. "That's a good thing," says Síle Lane from the London-based lobby group Sense About Science, which has pressed hard for transparency in a campaign called Alltrials.


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