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Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.
The European Medicines Agency has started to deliver on its promise of open access to clinical reports for new medicines authorized in the European Union. Peter O’Donnell reports on his experience accessing this database.
This column was hoping to bring you hot details of the European assessment process for Kyprolis (carfilzomib), an orphan cancer medicine for the treatment of multiple myeloma, and Zurampic (lesinurad), a medicine for gout. Today, October 20, is the day the European Medicines Agency has started to deliver on its promise of open access to clinical reports for new medicines authorized in the European Union.
As Vytenis Andriukaitis, European Commissioner for Health and Food Safety, said in announcing this breakthrough, "Transparency is an essential component in clinical research. Its outcome – whether positive or negative – should be made publicly available. EMA's transparency initiative will make Europe a true front runner with respect to release of data concerning clinical trials."
Well, up to a point, Lord Copper. Maybe this columnist is not smart enough to take advantage of this "transparency initiative". After filling in a number of online forms to acquire a password for the new service, and making repeated electronic requests for access to the data on these two drugs – the first ones to be listed on the site - I can still obtain nothing more than a message in red that says: "Not found" – along with a fuller statement that "the requested resource was not found". And since the EMA has closed for the evening, I will be unable to pursue my quest until tomorrow, when I shall seek their assistance.
Hopefully then I will be able to "directly access thousands of pages from clinical reports submitted by pharmaceutical companies to EMA in the context of marketing-authorization applications." The website is intended, says EMA in its announcement, to enable citizens, including researchers and academics, to access clinical reports that give information on the methods used and results of clinical trials conducted on medicines.
The boast is that EMA is the first regulatory authority worldwide to provide such broad access to clinical data. EMA’s Executive Director Guido Rasi has been an energetic promoter of transparency since he took over in 2011. “Our initiative has shaped the global debate towards more transparency. It will benefit academic research and the practice of medicine as a whole,” he said as the new website was launched. Certainly it does constitute some response to the growing chorus of demands for better information about regulatory decision-making. Anyone who wants it – in principle, anyway – can obtain fuller information about the data underpinning the approval of medicines, and academics and researchers will be better able to reanalyze data after a medicine has been approved. However, campaigners for transparency have reacted immediately with complaints that the scheme will not be fully retroactive – so data will not be included of older medicines – and not sufficiently that the information released has been screened and in some cases blacked out, to protect personal or commercial secrecy.
But the scheme also received a ringing endorsement from leading European patient advocate Yann Le Cam, Chief Executive Officer of EURORDIS-Rare Diseases Europe and member of the EMA’s management board. “Patients and clinicians have been waiting a long time for clinical trial data. This new approach will at last provide transparent information on all results of clinical trials, positive or negative, as submitted to the EMA”, he commented.
The website, available at https://clinicaldata.ema.europa.eu, will eventually include the clinical reports contained in all initial marketing authorization applications submitted to the agency since January 1, 2015. Today is just the start, with the release of 260,000 pages of information for over 100 clinical reports for Kyprolis and Zurampic, and more data will be progressively.
"This will be a learning curve for the agency and all its stakeholders, as they start to apply the policy for the first time," said EMA. Whether this columnist is a stakeholder or not, there is certainly a learning curve to be overcome. Perhaps tomorrow, after taking advice from the agency, I will be able to bring a glimpse of the information that the website tells me today "was not found".