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EMA changes ‘on screen’ data policy

Published on 16/06/14 at 10:46am
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The European Medicines Agency is to formally agree its policy on the vexed issue of the publication of clinical trial data, including what it calls ‘more user-friendly amendments’.

In essence, this means that there will be “the possibility to download, save and print the trial data for academic and non-commercial research purposes”.

Transparency campaigners such as AllTrials had been concerned that researchers would only be able to view information on-screen – but the EMA insists that it is now going ‘beyond its legal obligations’ to provide ‘an unprecedented level of access’.

Two consultations – from June to September 2013 and in May this year – “showed broad support for the policy, but highlighted concerns over the proposed view-on-screen-only access”, the regulator adds.

Last month, the respected medical journal BMJ attacked the EMA for ‘backtracking’ on public access to trial data, suggesting the regulator was reneging on its transparency drive following the adoption in the European Parliament of the new Clinical Trials Regulation, which will come into force in 2016.

The EMA management board met last week and agreed that the wording of the policy, “including practical arrangements for academic and non-commercial research users”, will be finalised by the middle of next month and effective from 1 October.

“Importantly, the agency will ensure that the policy will not prejudice citizens’ rights under existing access to documents legislation and the new clinical trials regulation,” the EMA says in a statement.

AllTrials claimed victory for the withdrawal of the ‘on-screen only’ element of the policy, saying on its website that this “only happened because hundreds of you called for it. If our correspondence hadn’t been tabled the changes probably wouldn’t have been voted through”, it added.

It still thinks that the EMA’s stance on redaction could still be a problem: pharma has said that putting black lines through parts of documents to render them unreadable might be necessary in some cases to ensure patient confidentiality.

“We remain deeply concerned at the EMA redactions policy, especially in light of the excessive and inappropriate redactions the Agency seems to have agreed with AbbVie, manufacturers of Humira,” says AllTrials co-founder Ben Goldacre.

“Doctors cannot make informed decisions about whether to use medicines such as Humira when important information about the clinical trials on that treatment are still being withheld from doctors, researchers and patients,” he adds.

In April AbbVie dropped its lawsuit against the EMA which had prevented it revealing data around Humira (adalimumab).

Adam Hill

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