Luto testing feeds into EMA consultation

Prof Theo Raynorold_guy-and-Luto-woman, co-founder and academic advisor to Luto Research responded to 2 recent European Medicines Agency consultations – related to the safety monitoring of medicines (called ‘pharmacovigilance’).

Both consultations related to the ‘Risk Management Plan’ which companies have to prepare for all licensed medicines. Prof Raynor’s comments relate specifically to the lay summary of the Risk Management Plan – Luto and the University have undertaken user testing of the new summaries with members of the public and his responses to the consultation are informed by this testing. Key findings from the testing include the importance of clear explanation of the document’s purpose and how it relates to other lay information about the medicine – tested wording for such an explanation are included in the response. The testing also showed how the proposed headings and sub-headings could be improved, and the need for to minimise the number of columns in any tables – generally no more that 2 or 3. In his response he emphasises the importance of testing documents written for the general public to be tested with ‘real’ people – not just with ‘expert patients’ and people working for patient organisations.

His combined responses can be found here:

Response to European Medicines Agency Consultations from Professor DK Theo Raynor

You can also find slides from the DIA conference which describe the user testing, and a copy of a Risk Management Plan summary, revised after user testing.