Inspecting Ali Baba's Cave of EMA Drug Data

Oct 21, 2016

The rock has been rolled away that barred this columnist's entrance to the European Medicines Agency's new website of detailed information on products it has assessed. The press office helpfully advised me that I had omitted a crucial step in my registration, and once I had performed a further maneuver at the entrance, I was inside, and free to roam through this extraordinary cavern, that allows anyone to pick up for inspection whatever catches their fancy among the horde of files on display.
 
As the EMA claims, the information is comprehensive. On the two medicines included so far – Kyprolis and Zurampic - there are a quarter of a million pages of information for over 100 clinical reports. The website is to include the clinical reports contained in all initial marketing authorization applications submitted since the start of last year, as well as applications to vary a marketing authorization for an extension or modification of indication or a line extension.
 
For anyone familiar with authorization applications – and that will be most readers of this column – there is of course little that is surprising in the format. The 88-page clinical overview of the application for authorization of Zurampic concludes with the unsurprising statement that "the results of the comprehensive lesinurad clinical program consistently support the conclusions that the proven benefits outweigh the documented risks for lesinurad 200 mg in combination with a xanthine oxidase inhibitor as a chronic treatment for hyperuricemia associated with gout."

Similarly, for Kyprolis the overall conclusion is that, "In summary, we believe that Kyprolis, Revlimid and low-dose dexamethadone represents a new standard of care in the treatment of subjects with relapsed multiple myeloma. A favorable benefit: risk profile was noted in the proposed indication with significant gains in progression free survival, trend in overall survival, increased complete responses and improved quality of life, achieved with a well-tolerated triplets compared to randomized control."

What is surprising is the public availability of this detail and extent of information. Anyone wanting to do so can consult any one of hundreds documents, ranging from the clinical overview addendum and clinical justification to detailed errata (such as "An error was made in the reporting of data from study 201. Data reported from Day 8 of that study were mistakenly reported as being for the 200 mg dose during steady-state administration, when in fact the data were following the first dose of the 400 mg treatment.") In the section on clinical study reports for Zurampic nearly 300 pdfs are on offer, with alluring titles such as rdea594-203-ol-ext-app1611-protocol, rdea594-302-app1619-sap, rdea594-117-s-csr-body, or summary-clin-safety-iss-table-26.
 
Every page in the documents is conspicuously watermarked with an EMA "keep off the grass" statement that "This document cannot be used to support any marketing authorization application and any extension or variation thereof". And access to each document is protected by an explicit requirement of a commitment to comply with the rules of this new game: "In order to view the document please accept the Terms of Use by clicking the check box," users are invited – in a way that does not permit any concessions.
 
Loading and manipulation is a bit slow – perhaps inevitable given the size of many of the documents – and some passages are blanked out on the grounds of protecting personal or commercial privacy. "While the policy gives an unprecedented proactive access to clinical data, it also demands the highest standard of protection of patients’ personal data," says the EMA.
 
Although there are only two products on the website as of today, the promise is that, "The process will evolve over time," and data will be progressively added online for all applications. Once the initial backlog has been dealt with of products that have long ago completed their passage through the regulatory pipeline, the EMA aims to speed up publication of the reports, within 60 days of a European Commission decision, whether positive or not, and within 150 days after the receipt of a withdrawal letter.
 
And all you need is an electronic "open sesame". Go to https://clinicaldata.ema.europa.eu.

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