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BMJ slams EMA ‘U-turn’

Published on 30/05/14 at 08:16am
EMA building
EMA headquarters

The BMJ has attacked the European Medicines Agency for what it believes is a decision to ‘backtrack’ on public access to clinical trial data.

In effect the respected medical journal, which is tied to the UK-based AllTrials campaign, is accusing the regulator of 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 has wrestled with transparency issues over the past couple of years, saying it “is committed to pursuing the objective of full transparency regarding clinical trial data” because it believes that the release of data contributes to “establishing trust and confidence in the system”.

BMJ says that EMA’s long-awaited policy on transparency suggests that clinical study reports are now likely to be available only to registered users through ‘controlled access’ in a ‘view on screen only’ mode.

The BMJ also points out that “information could be redacted if study sponsors deem it confidential”. The regulator’s management board meets next month to finalise the policy.

Much of the debate about putting black lines through parts of documents to render them unreadable relates to ensuring patient confidentiality - something that pharma has raised concerns about.

But BMJ says the authors of the first ever Cochrane reviews ‘are aghast’ at this, saying they “could not have properly reviewed and cross checked the thousands of pages from Roche and GlaxoSmithKline if those companies had imposed conditions like those EMA is now proposing”.

However, in an editorial, BMJ head of research Trish Groves and European research editor Wim Weber acknowledge that, even with this “watered down policy, EMA will be making visible vast quantities of new regulatory information…about randomised controlled trials of drugs” and “other types of interventional or observational clinical research methodologies”. 

“Despite setbacks, great strides have been made in the past three years towards clinical trial transparency,” the authors say.

Still they warn that a ‘great deal’ remains hidden from policymakers, doctors and patients - and if the regulator stops releasing data on old trials, which is currently possible on request, “we will all be even more in the dark”.

This is why AllTrials is still campaigning for more openness, which means the “research, advocacy, haggling and politics must go on”.

The EMA says it had to take stock of ‘diverse views’. “The challenge in this exercise was to find a balance between the often competing views that would allow the Agency to move forward with its policy,” it says in a statement.

“The Agency believes its policy finds an acceptable balance between all those competing interests,” it insists.

Last month AbbVie dropped its lawsuit against the EMA which had prevented it revealing data around its drug Humira (adalimumab).

Adam Hill

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