The unexpected backtrack for clinical trial transparency in Europe

Following the recent revelation that the EMA’s policy on proactive publication of clinical trial data wasn’t quite what had been expected, we look at how this will impact future research and developments in transparency.

Medical bottles_copTransparency surrounding clinical trials has been one of the hottest topics of recent years. A day doesn’t pass without a study or blog bringing it to our attention, and for good reason; without access to all clinical trial data it is impossible to make informed clinical decisions, which puts people at risk.

Over the last few years, initiatives and pledges to increase transparency have come from all directions, from regulators to pharmaceutical companies, and from publishers to researchers. We have the AllTrials initiative, the passing of the EU Clinical Trials Regulation, Johnson & Johnson working with the Yale Open Data Access (YODA) Project and the Restoring Invisible and Abandoned Trials (RIATs) initiative, to name but a few.

This is why the apparent ‘U-turn’ by the European Medicines Agency (EMA), backing away from its policy on publication and access to clinical trial data has caused such a tremendous uproar.

Let me begin by taking you back to 2010, when the EMA bought into effect its policy on access to documents. This meant the EMA were now able to release clinical study reports that were used during the marketing authorization application of a new medicine in Europe. Then they announced plans to proactively publish clinical trial data for medicines that have completed the marketing authorization process. No need to apply for access to the data, the data would be readily available. It looked like things really were really moving forward in Europe.

Their next step, in June 2013, was to release the draft policy on the proactive publication and access to clinical trial data. Its development involved multiple European bodies and stakeholders, including patient and consumer organizations, healthcare professionals organizations, pharmaceutical industry representatives, researchers and medical journals, as well as public consultations. The involvement of these stakeholders ensured the EMA was able to consider the various, and often competing, interests of all those that this policy would effect. The EMA stated that this policy would act as a ‘bridge’ in their commitment to increasing transparency between now and mid-2016, when the EU Clinical Trials Regulation is set to come into place.

Three weeks ago, the EMA held its last round of targeted stakeholder consultations to discuss the finalization of the policy, where it came to light that they aren’t going to do quite as much for transparency as initially believed; the clinical study data they promised would be in a potentially edited state, and in the overall scheme of things, you would not be able to use the data. The EMA have stated, “the Agency believes its policy finds an acceptable balance between all those competing interests”, but the extent of the compromise is now under huge criticism.

First, although the EMA will not vet those who request access to Papers and laptopthese documents, they will be required to sign a contract recognizing the data is protected by copyrights and could be classed as commercially confidential.

Second, even though the EMA stated the policy will allow “access to clinical trial data in an analyzable format” all data will be ‘view-on-screen only’. There will be no downloading, saving, editing, photographing, printing, distributing or transferring of the data. In other words, you cannot use the data.

Third, the ‘view-on-screen’ only clinical study report would be in an unknown redacted state. When pharmaceutical companies submit a marketing authorization application to the EMA they will be asked for two copies of the clinical study report, one full and one redacted. The redacted report will not state where in the report information has been removed from (and could include novel statistical or other analytical methods), with no justifications as to why information has been redacted. The public will be completely unaware of what’s missing.

Some of the main concerns surround how this change in direction relates to the EU Clinical Trials Regulation. European Ombudsman Emily O’Reilly wrote to the EMA asking them to explain their change in direction regarding transparency, and to put it in context of the Regulation. Their reply stated that the policy and Regulation are separate and distinct from one another, and that there has been no change in direction.

The main suspicions as to why this ‘U-turn’ has occurred circulate around the concern of unfair commercial advantage by pharmaceutical companies, even though the EMA themselves have said clinical study reports do not classify as commercially confidential.

An interview with Emily O’Reilly published earlier this week highlighted concerns that these changes are linked to the recently dropped AbbVie case against the EMA in regards to releasing clinical trial data.

The EMA said they would release summaries of the final round of stakeholder meetings, including the meeting with pharmaceutical industry representatives, which may have shed some light on their decisions. But, it is now clear these will not be published until after the policy has been finalized on 12 June when the EMA meets with its management board. As Jim Murray rightly says, this is “policy making behind closed doors”.

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UPDATE 16/06/14 – Following the EMA management board meeting on 12 June, the EMA agreed the policy for proactive publication of clinical trial data will have “more user-friendly amendments” compared with the draft policy shared at the stakeholder meetings in May 2014.  This includes the “possibility to download, save and print the trial data”.  However, the exact wording of this amendment is still to be finalized, and concerns still surround the redaction and terms of use policies.

The policy itself is to be finalized by mid-July 2014, and will be effective from 1 October 2014.

UPDATE 02/10/14 – The EMA management board is meeting today to finalize wording amendments and the  formal adoption of this policy.

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