Lay-friendly language & graphics
The creation of a lay summary might be time-consuming and costly. The achievement of appropriate lay-level readability and sound graphical presentation might require special writing and design skills, specifically when creating lay summary for a paediatric audience. To achieve optimal results it is useful to engage experienced medical writers and graphic designers. Furthermore, the European Expert Group provides recommendations including suitable descriptions in plain language for common endpoints used in clinical trials.6
Presentation of safety information
Another challenge is the presentation of safety information. Generally, a description of the most frequent adverse events related to the investigational product (drug-related adverse events) is sufficient. However, readers may confuse drug-related adverse events captured at trial level with side effects presented in the package leaflet.1 Medical Dictionary for Regulatory Activities (MedDRA) preferred terms are usually difficult to understand by laypersons. A simple but accurate description as well as a concise glossary is useful to overcome this challenge.
Sponsors need to keep in mind that the lay summary must be strictly non-promotional. Anything that could lead to possible consideration as promotional material must be avoided. This includes not only the presentation of results, but also the visual appearance and way of dissemination. Thus it is strongly recommended to avoid tradenames, create a balanced and objective presentation (i.e. do not highlight positive outcomes while minimizing negative results), and avoid absolute claims (e.g. “the results clearly proved”) as much as possible. If lay summaries are published on a website, only non-promotional content should be hosted.1
Review process & translation
When translating the lay summary, translators need to ensure that the translation is accurate and that native readers consider the language adequate. Additionally, the translation bears the risk of creating content differences between the master version and the translated summaries. Therefore, a back translation process is encouraged.
Lastly, as the early involvement of laypersons, in particular patients, in the development and review process is highly encouraged, sponsors should identify and network with patient associations, representatives or advocacy groups. Once relationship is established, this cooperation holds the potential benefit of directly engaging with key stakeholders.