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• Response from the European Medicines Agency
  Isabelle Moulon
  Published on: 4 October 2013

• Published on: 4 October 2013

  Response from the European Medicines Agency

  • Isabelle Moulon
  • Other Contributors:
    • Juan Garcia Burgos, Inga Abed, Paul Blake, Federica Castellani, Nacho Mbaeliachi and Marialuisa Spanu

  The European Medicines Agency (EMA) welcomes the research on the usability of the summaries of the European Public Assessment reports (EPAR summaries) by Professor David K Raynor and David Bryant recently published on the BMJ Open website.

  The EMA had first become aware of the results of this user-testing study in 2011 while the Agency was already consulting stakeholders on improving the EPAR summaries, aiming a...

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  The European Medicines Agency (EMA) welcomes the research on the usability of the summaries of the European Public Assessment reports (EPAR summaries) by Professor David K Raynor and David Bryant recently published on the BMJ Open website.

  The EMA had first become aware of the results of this user-testing study in 2011 while the Agency was already consulting stakeholders on improving the EPAR summaries, aiming at making them easier to read by a lay audience. Although the limitations of the study pointed out by the peer reviewers (such as the suitability of the questions, the representativeness of the participants and the fact that only one summary was user tested) reduced its applicability, the EMA included the results as input to this process.

  Using feedback from various stakeholders, but particularly patients and healthcare professionals, the format and content of EPAR summaries were updated in 2012 and this standard is now being used for all new summaries and to gradually update old summaries on the EMA website. The study by Raynor and Bryant used an EPAR summary prepared in 2009, which precedes these extensive changes. Although the changes introduced during the update in 2012 went beyond the scope of the authors' user-testing, the EMA believes that the results of the study are addressed by the current EPAR summary template.

  The EMA continues to encourage research in the area of public communication, particularly on the use of lay-language documents, and thanks the authors for conducting this important research.

  Conflict of Interest:

  The European Medicines Agency is the owner of the EPAR summary documents

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  Conflict of Interest:
  None declared.

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