Mixed response to EMA data transparency plans
The European Medicines Agency has passed new rules that will mandate pharma to release more of its clinical trial data from the start of next year.
In what its executive director Guido Rasi describes as an ‘unprecedented’ step forward, the EMA has now decided to publish the clinical reports that underpin the decision-making on medicines.
Following extensive (and repeatedly delayed) consultations held by the Agency with a number of stakeholders over the past 18 months, the EMA’s management board unanimously adopted the new policy at its meeting yesterday afternoon.
The policy will begin from New Year’s Day, 2015 and will apply to clinical reports contained in all applications for centralised marketing authorisations submitted after that date. The reports will be released as soon as a decision on the application has been taken.
More data will be released as the EMA is to publish the information in stages; the first phase starts on 1 January and means that once a medicine has received a marketing authorisation, the EMA will publish the clinical reports supporting applications for authorisation of medicines submitted after the policy’s entry into force.
For line extensions and extensions of indications of already approved medicines, the Agency will give access to clinical reports for applications submitted as of 1 July 2015, after a decision has been taken.
The Agency will also look to add a third stage and says in a statement that in the future it plans to also make available individual patient data. But this is a tricky area, and one that pharma has lobbied against, saying this could open up privacy concerns.
To address the myriad legal and technical issues linked with the access to patient data, the Agency says it will first consult patients, healthcare professionals, academia and industry, before coming up with any new plans in this area.
It adds that “it is critically important for EMA that the privacy of patients is adequately protected before their data are released”.
Rasi says: “The adoption of this policy sets a new standard for transparency in public health and pharmaceutical research and development. This unprecedented level of access to clinical reports will benefit patients, healthcare professionals, academia and industry.”
The new EMA policy will serve as a ‘useful complementary tool’ according to the Agency, ahead of the implementation of the new EU Clinical Trials Regulation that will not come into force before May 2016.
This new regulation was voted into law in April and contends that information from clinical trial study reports should generally not be considered commercially confidential, thus removing the legal framework for pharma to not publish its data.
The EMA has come under pressure from pharma and its European lobby group EFPIA over these plans, but says it has decided to expand the transparency agenda to “increase trust in its regulatory work as it will allow the general public to better understand the Agency’s decision-making”.
The new policy will allow academics and researchers to be able to re-assess data sets, and the publication of clinical reports should also help to avoid duplication of clinical trials, foster innovation – and encourage development of new medicines.
But there is still the threat that some information could be blacked out from public view, a situation known as a redaction.
The EMA says that any information that may be considered commercially confidential will in fact be redacted, although it stresses this will be a rare occurrence and that the final decision on such redactions rests with the Agency, not a pharma company.
This is very much a victory for the British-based AllTrials pro-transparency group, which was set up in 2013 by Sense About Science, the BMJ and Bad Pharma author Dr Ben Goldacre, and has been lobbying the EMA hard to bring in these new plans.
Professor Carl Heneghan, director for the centre for evidence based medicine at Oxford University, was pleased with yesterday’s vote.
He says: “The EMA’s announcement on the publication of clinical reports is a major step forward and represents a real shift in favour of ensuring research data is shared routinely and re-used effectively in the public interest.”
He adds that this also “sets a standard for data transparency now and in the future”.
But he is still concerned that many older drugs will not fall under this remit which is a problem, as most of the drugs used in the EU would have been approved before 2015.
He says that the EMA’s attitude to redactions should be independently audited to ensure “overzealous approaches do not hinder access to important information” on benefits and harms contained within clinical study.
Goldacre was less impressed, adding: “Firstly, the EMA records are woefully incomplete for informed decision-making: EMA only holds clinical study reports (CSRs) for a small proportion of all the trials done on all the medicines we use today.
“We need a radical overhaul giving retrospective transparency on all CSRs from industry, and clear transparency on methods and results for all trials done by academics. Secondly, this policy does nothing to move forward on the safe sharing of individual patient data – whilst respecting patient privacy – which was promised by EMA in 2012.
“Lastly, there are serious concerns around the redactions process. For this, we can only go on recent performance, which is not encouraging.”
Goldacre notes that earlier this year the EMA reached an agreement with AbbVie to censor information on protocol changes from the public release of a CSR.
“Protocol changes in a trial are precisely the kind of information that researchers need to make an informed decision about whether that trial was a ‘fair test’ of the treatment,” he says.
“It is hard to see how it is justifiable to hide protocol changes, in a trial from eight years ago, on over-riding grounds of commercial confidentiality.”
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