European Clinical Trial Data Open By 2014

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On 22 November a workshop took place at the European Medicines Agency on access to clinical-trial data and transparency. Earlier in July we reported that the EMA was going to prepare publishing clinical trial data as a major step towards transparency in the thus far very secretive world of the USD $1 trillion global pharmaceutical market.

The European Medicines Agency is committed to proactive publication of clinical-trial data, once the marketing-authorisation process has ended. We are not here to decide if we publish clinical-trial data, but how.”, said Guido Rasi, Executive Director of the Agency, in his opening statement.

In the spring of 2013, it was decided at the workshop that policies will be formulated in five areas:

  • protecting patient confidentiality;
  • clinical-trial-data formats;
  • rules of engagement;
  • good analysis practice;
  • legal aspects.

For all of these areas an advisory group will be formed that will be expected to present their work by the end of April 2013. Details about how to express interest in participating in these advisory groups will be published shortly on the Agency’s website.

By January 2014 pro-active publishing of clinical trial data should commence.

In the mean time reactive disclosure of data remains unchanged. Since November 2010, the Agency has released over 1.5 million pages of clinical-trial data in response to safety-related requests.