EMA Transparency: New Clinical Reports Go Live

Regulatory NewsRegulatory News | 20 October 2016 |  By 

The European Medicines Agency (EMA) on Thursday kicked off its effort to proactively publish clinical trials data with the release of clinical reports for two drugs, Kyprolis and Zurampic, via a new online database.

"Transparency on clinical data is a longstanding commitment from EMA and today, we are delivering on our promise to give access to the data on which our recommendations are based," said EMA Executive Director Guido Rasi, adding that the initiative "will benefit academic research and the practice of medicine as a whole."

Clinical trial transparency has been a concern of public health advocates and regulators for decades. According to a recent Health Affairs report, "up to half of all clinical trials never have their results published." Additionally, clinical trials with negative results are far less likely to be published than those with positive ones.

EMA says its new policy will address that issue by publishing the results of all trials submitted to the agency, regardless of whatever the product is ultimately authorized, rejected or withdrawn.

Specifically, EMA says it will publish the clinical overview, summary and study reports, including data from several appendices (protocol and protocol amendments, sample case report forms and documentation of statistical methods) for all marketing authorization applications, so-called Article 58 procedures, as well as applications for new indications and variations to already-approved drugs.

Going forward, EMA says it will work to tackle the backlog of clinical reports for marketing authorization applications and variations submitted after the policy went into effect (1 January 2015 for initial marketing applications and 1 July 2015 for variations).

Once the backlog is taken care of, EMA says it plans to publish clinical reports for future applications within 60 days of a European Commission decision on the drug. EMA says it will also publish the clinical reports for withdrawn applications within 150 days of being notified of their withdrawal.

The amount of data contained within the reports is staggering. According to EMA, the data released today for Kyprolis and Zurampic total roughly 260,000 pages of information from more than 100 clinical reports.

Currently, EMA says it expects to publish 4,500 clinical reports per year, all of which must be reviewed and redacted to mask both commercially confidential and patients' personal data.

EMA Deputy Executive Director Noël Wathion said the effort will be "resource intensive," noting that the agency has not taken on additional staff to assist with the workload.


One of biggest challenges EMA faces with the new policy is ensuring it protects patient and commercially confidential data.

For each application, sponsors must submit a redaction proposal to EMA detailing the information they wish to have redacted before publication. For patient data, this includes an anonymization report, "which describes the application's [protection of personal data] anonymization methods and their impact on data utility."

Additionally, the agency says it will redact commercially confidential information only where necessary, but says that very little data in the reports should be considered commercially confidential.

"The amount of commercial confidential information in clinical reports is extremely limited … out of the 260,000 pages which we will release today, only two pages contain commercial confidential information that has been redacted," Wathion said, noting that no data was redacted for commercial confidentiality in the data released for Kyprolis.

Possible Legal Challenges

EMA is currently fighting legal challenges due to its 2010 access to documents policy, which allows third parties to request access to clinical trials reports. The lawsuits could potentially disrupt the agency's efforts to proactively publish clinical reports.

Last month, the President of the General Court of the European Union ordered EMA to halt the release of information on studies relating to two approved drugs, PTC's Duchenne muscular dystrophy drug Translarna and Intervet's veterinary flea and tick treatment Bravecto.

In both cases the companies argue that EMA would infringe on their right to protect commercially confidential information contained in their dossiers by releasing the data, in this case a clinical study report for Translarna and three toxicity studies for Bravecto.

However, EMA has already appealed the orders, arguing that the release of such information is in line with the EU Transparency Regulation.

"Our position that clinical reports are not confidential per se was confirmed by the adoption of the recent Regulation on clinical trials. They may contain some residual commercially confidential information which should be redacted. However, a sort of 'blanket' protection from disclosure for documents supporting an authorisation for a medicine seems neither consistent with the legislation nor advocated by our stakeholders," said Stefano Marino, head of EMA's legal department.

Wathion echoed this stance, saying the same would apply to the proactive publication of clinical data as well.

"There can be no general presumption of confidentiality, so there can be no blanket protection as such. That is also an approach we have defended successfully in previous cases … on the redactions that are being proposed in terms of commercial confidential information, the approach of the EMA is not different in terms of access to documents versus this proactive publication of clinical data, and we are confident that this approach is the correct one," he said.



© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy