European Public Assessment Report (EPAR) summaries for the public: are they fit for purpose? A user-testing study
Making European Public Assessment Reports (EPARs) accessible to the public through a summary is a great idea and the EMA should be applauded for the initiative. This research shows however that formatting and content could be improved through ‘user testing’ with members of the public – a process which pharma companies and others now routinely use to ensure the fitness for purpose of medicines information. EPAR Summaries are produced by the EMA, not pharma and so do not have to go through the user testing process, and this research shows how useful that can be.
The quantitative component (can people find and understand the information they need) showed that the layout, headings and design needed improving, and the qualitative part (allowing participants to give their views and opinions) showed that people needed better information at the start to clarify the purpose of the document – what it was for and why they should read it. People also talked about the need to link the EPAR summary to the patient leaflet. This research was funded by the University of Leeds, in collaboration with Luto – further evidence of the synergies in this academic-commercial link up.