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EMA transparency policy delayed over 'wording'

Regulation on access to trial data postponed until October
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The wait for the European Medicines Agency's much anticipated policy on clinical transparency will go on a little longer, after the regulator's board said it would need longer to finalise the document.

The controversial policy - which was due to be published this month - will not now be ready for enactment until October, said the EMA, which said the delay was caused by a need for "further clarifications on wording and practical arrangements".

The EMA's proposals were warmly welcomed by proponents of clinical trial transparency when they were first disclosed in draft form last year, but over the intervening months the agency has been accused of watering them down following pressure from the pharmaceutical industry.

EMA board members seem to be in support of the overarching themes in the policy, including a June amendment that made it easier for independent researchers to review clinical study reports (CSRs).

An earlier draft had suggested CSRs could only be viewed on-screen and not downloaded, saved or printed and trial sponsors would be able to redact portions of the a reports, two measures that were roundly criticised by transparency advocates such as the AllTrials campaign.

Meanwhile, European Ombudsman Emily O'Reilly also expressed concerns about a proposed exemption to the requirements for 'commercially confidential' information.

A letter sent by O'Reilly to the EMA in May indicated she was concerned with "what appears to be a significant change in EU policy" which could undermine "the fundamental right of public access to documents established by EU law".

The changes represented a shift from "proactive transparency to a restrictive policy" that could be at odds with the European Parliament vote in April in favour of legislative proposals to make clinical trial data public, she added.

AllTrials issued a statement in the wake of the EMA announcement suggesting the delay may in itself represent an opportunity. "This means we have another chance to persuade the EMA to go back to the better policies they proposed last year," it said.

The EMA said the delay meant there would be an additional round of discussions to tackle the "political and technical aspects" that have emerged during the consultation phases.

It insisted it has tried to strike a balance between "proactive data disclosure, the absolute need to protect personal data and the concerns relating to the protection of commercially confidential information".

Vaccine trial results unreported

The need for reform of the clinical data transparency policy was emphasised by a recent study in the British Medical Journal (BMJ) which suggested results of 19 out of 384 vaccine trials registered on the website remained undisclosed six years after they concluded. The unreported studies involved more than 11,500 patients, say the authors.

"Most vaccine trials get published eventually or have results posted in, but delays of several years to publication are common," they write, adding that investigators and sponsors have an ethical obligation to study participants to publish trial results.

"Unpublished trials produce no scientific and social benefits, and their expenses, often large, are wasted.

11th July 2014

From: Regulatory



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