Sponsors of clinical trials are required to provide result summaries in a format that is understandable to laypersons, as outlined in the EU Clinical Trials Regulation 536/2014 (Article 37) (EU CT Regulation). After a period of public consultation, the EU’s guidance ‘Summaries of clinical trial results for laypersons’ was published in January 2017. Recently, Theo Raynor, Professor of Pharmacy Practice at the University of Leeds, has written an article summarising the guidance and outlining the important steps to consider when writing such a critical piece of commentary.
Raynor points out the difference that “lay-friendly headings” make to the readability of the article and that although the piece should be concise and kept as short as possible, this should not be to the detriment of technical explanations. Layout and design can be used to guide the reader through a lengthier document. He suggests that a conversational approach to writing should be adopted as many lay people “communicate by talking, listening to conversations, the radio and television” rather than through reading and writing. The use of graphics or visuals should be carefully considered, as even simple graphs can be misinterpreted. Raynor finishes with the reiteration that the document provided by the European Commission is for guidance purposes and should not deter writers from using “innovation in improving summaries’ usefulness”.