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EMA: We will allow clinical data download

Regulator says it hasn't watered down trial transparency measures
EMA 'will allow' clinical data download

The European Medicines Agency (EMA) has been forced to defend itself from accusations it has watered down measures to make data from clinical trials available to researchers.

A draft policy that circulated in May had raised concerns that the agency's steadfastness in pursuing transparent publication of clinical study reports (CSRs) - something that it had been vocal about pursuing - was waning.

Specifically, the draft seemed to indicate that CSRs would only be viewed on screen and not downloaded or saved, undermining their use by researchers. It also suggested that it might be possible for pharma companies to redact portions of the reports.

At a board meeting yesterday the EMA agreed the policy on the publication of clinical data, along with amendments proposed by its executive director Guido Rasi, which will allow the agency to proactively publish clinical trial data that are submitted as part of marketing authorisation applications.

However, a statement issued at the end of the meeting stressed that the policy "give[s] the possibility to download, save and print the trial data for academic and non-commercial research purposes."

The agency has only recently emerged from a consultation period on its proposals and has faced intense pressure from the pharma industry on one hand - including lawsuits filed by AbbVie and InterMune seeking to block the release of data, with the recent vote for greater transparency by the European Parliament on the other. AbbVie dropped its lawsuit against the EMA in April, while InterMune has reportedly discontinued at least part of its own litigation. 

Recent comments from the EMA acknowledge that its policy is a compromise and suggest it is viewed as a holding position ahead of the implementation of the new clinical trials regulation in 2016.

In a letter to AllTrials earlier this month, Rasi stressed that the EMA does not have law-making powers, adding that the draft was shaped "in the absence of any specific legal provision mandating the EMA to publish documents submitted to the agency by third parties".

Opponents of full transparency have argued that the policy would disadvantage the European pharmaceutical industry by giving away commercially-sensitive information and discouraging R&D. On the other side, organisation such as Germany's health technology assessment authority IQWIG, the British Medical Journal (BMJ) and the AllTrials pressure group say that disclosure is essential to allow researchers to properly gauge the value of medicines to public health.

The reality is that the EMA board has only agreed the overall themes of the policy and with the wording still to be finalised - including the practicalities of allowing researchers access to CSRs - and the situation remains pretty opaque.

In a statement released yesterday, the EMA insisted its policy takes it "beyond its legal obligations and provides an unprecedented level of access to clinical trial data that are used as part of decision-making for new medicines".

13th June 2014

From: Research, Regulatory



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