EU regulator begins publishing detailed study data

Europe’s regulator has finally given access to clinical study reports for new medicines, allowing public scrutiny of detailed data on new medicines for the first time.

The European Medicines Agency (EMA) has been struggling with this issue for several years, and the launch of the scheme has been delayed as the regulator attempted to balance the need for transparency, with pharma companies’ desire to keep sensitive commercial information secret.

However the EMA has finally begun making clinical reports public, starting with Amgen’s Kyprolis (carfilzomib) for multiple myeloma and AstraZeneca/Grunenthal’s gout medicine, Zurampic (lesinurad).

The EMA said patients and healthcare professionals will be able to find out information about the data underpinning approval of medicines they are taking or prescribing.

Academics and researchers will be able to access thousands of pages from clinical reports that support EU filings.

Data is available on a special website set up by the EMA, which noted that it is the first regulator to make this information available to the public.

The website will include clinical reports contained in all applications submitted on or after 1 July 2015. It also includes filings to extend or modify indications after that date.

The EMA will also publish documents when applications are withdrawn before it has given an opinion.

This will include information on methods used and details of results of clinical trials conducted on medicines.

There are around 260,000 pages of information contained in over 100 clinical reports for Kyprolis and Zurampic.

Once the EMA has worked through its backlog, it aims to publish reports within 60 days of a regulatory decision, or within 150 days of receipt of the withdrawal letter.

The EMA admitted that it may need to re-assess the feasibility of these timelines given it expects to publish around 4,500 clinical reports annually.

The EMA’s executive director, Guido Rasi, said: “Transparency on clinical data is a longstanding commitment from EMA and we are delivering on our promise to give access to the data on which our recommendations are based.

“Our initiative has shaped the global debate towards more transparency. It will benefit academic research and the practice of medicine as a whole.”

However not everyone was convinced by the EMA’s announcement. Clinical trials transparency campaigner Ben Goldacre referred in a tweet to an earlier instance where the EMA had published clinical reports relating to AbbVie’s Humira (adalimumab) inflammatory diseases drug following a public request.

The European Ombudsman ruled earlier this year that the EMA had redacted too much information from the reports published, which was deemed by AbbVie to be commercially confidential.

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