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EMA delays data transparency

pharmafile | November 14, 2013 | News story | Medical Communications, Research and Development, Sales and Marketing EMA, FDA, all trials, transparency 

The European Medicines Agency has delayed its much-trailed plan to launch a clear policy on making clinical trial data publically available at the end of this year.

Europe’s drugs regulator now admits that it will not know when the start date will come – but says it will miss the 1 January deadline.

The vexed question of data disclosure encompasses a range of issues – among them patient and commercial confidentiality – and has been a subject of great debate.

As a consequence, the EMA says it is “currently reviewing and analysing more than 1,000 comments received during the public consultation on its draft policy”, which ended in September.

While it is ‘grateful’ for the scale of the response, which it says is an ‘exceptional contribution’ – the time taken to go through them all has slowed up the process.

“In order to conduct the appropriate in-depth analysis required, the Agency will spend additional time in this reviewing phase which may therefore delay the finalisation of the policy initially planned for the end of 2013,” the EMA said in a statement.

Comments came from a range of contributors including pharma companies, patients, doctors, transparency campaigners and academics, “some of them substantial, some of them technical, including suggestions relating to methodological and technical aspects of the implementation of the policy”. 

The consultation ran from June to the end of September – the EMA would not respond to questions about whether it was surprised by the level of response or whether it thought critics might say it had had sufficient lead-in time to stick to its original timetable.

The EMA added only that it would provide an update on timing following the next management board meeting on 11-12 December.

The EMA has been criticised in the past for a lack of transparency – in sharp contrast to its US counterpart the FDA, which has generally allowed its deliberations to be open to greater scrutiny.

The European regulator insists it is “currently devoting attention to all comments received and reaffirms its commitment to transparency and the principles of publication and access to clinical trial data”.

But it has been under pressure by the European pharma group EFPIA to not release data and instead allowed the industry to self-regulate when it comes to disclosure.

Both AbbVie and InterMune are currently sueing the Agency after it released data on two of their medicines, putting the future of transparency on a tricky path.

This delay will only add to the frustration felt by pro-transparency groups, such as the UK-based AllTrials, which wants all data to be published as soon as possible.

Adam Hill

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