EMA’s five points on data release
pharmafile | November 27, 2012 | News story | Medical Communications, Research and Development, Sales and Marketing | EFPIA, EMA, Rasi, transparency
The European Medicines Agency has highlighted five areas that need to be ironed out before it begins publishing clinical trial data – without anyone asking for it – in January 2014.
The drugs regulator says: “There are practical issues and other considerations that need to be addressed and resolved.”
But executive director Guido Rasi has already affirmed: “The EMA is committed to proactive publication of clinical trial data, once the marketing authorisation process has ended.” He added: “We are not here to decide if we publish clinical trial data, but how.”
The EMA says its workshop last week on access and transparency ‘kicked off’ the process by which it will publish trial results.
The importance of the move, if it comes off, is that it will allow data – usually presented by pharma companies with the express intention of getting their drugs to market – to be re-analysed by anyone who wants to.
The EMA’s stated aim is to “build trust and confidence in the system”, and advisory groups will start working early next year on exactly how this is going to look in practice.
Senior medical officer Hans-Georg Eichler said the EMA had come up with five areas to examine, based on the workshop sessions:
- protecting patient confidentiality
- clinical trial data formats
- rules of engagement
- good analysis practice
- legal aspects.
Final advice from each working party is expected by the end of April 2013.
So much for the EMA’s future policy of ‘proactive’ disclosure – the organisation says its ‘reactive’ disclosure stance has already meant that 1.5 million pages of trial data has been released in response to safety-related requests since November 2010.
While European pharma body EFPIA has warned against the ‘indiscriminate’ release of data, Roche said last week that it will let researchers have access to more on influenza vaccine Tamiflu.
Adam Hill
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