Risk Management Plan lay summaries – are they fit for purpose?
Luto co-founder and academic advisor, Professor Theo Raynor had the opportunity to present his thoughts on the new Risk Management Plan lay summaries at two recent DIA events; the Annual Euro Meeting in Vienna and the European Forum for QPPV in London.
In Vienna, Theo gave a ‘temperature check’ on the lay summaries, based on the first examples just released by the European Medicines Agency (EMA). He noted that the press release accompanying the first summary claimed that the initiative ‘increases transparency and public access to relevant information on medicines’. However, he described how the guidance for companies on writing the summaries includes wording which does not appear lay–friendly, highlighting as an example the heading ‘Overview of disease epidemiology’. Professor Raynor suggested that less than 5% of lay people would understand this heading, meaning such wording needs to be reconsidered.
In a more detailed presentation to the QPPV audience, he noted the lack of context in the lay summaries – which launch into detail, without first explaining the purpose of the summary i.e. who it is for and why it was prepared. He also noted the complex tables which predominate in the current summaries – for example with five columns and many more rows, which would be beyond the capabilities of many lay people.
In his overview, his message was that the purpose of the summaries needs to be spelled out, the headings made more
lay-friendly and the tables simplified. Professor Raynor noted that ‘User Testing’ of two examples of the new Risk Management Plan lay summaries is about to begin, facilitated by Luto. He hopes that the results of this testing will feed in to the review which the EMA say they will undertake after the first year of lay summaries being made available. He expressed confidence that the summaries can be made fit-for-purpose, citing the example of EPAR lay summaries, which have been significantly improved through the EMA taking on similar feedback from a number of sources.
Luto has gained a wealth of experience in developing Risk Management Plan lay summaries over the last year, making sure they meet the needs of the intended end-user. Get in touch today to find out how Luto can help you develop your Risk Management Plan lay summaries.