There is an increasing trend towards focus on patient and data transparency in the pharmaceutical industry. However, the complex nature of scientific information and the technical language commonly used in regulatory documents pose major challenges for patients to understand the available information.
For clinical trials, this need is addressed by lay summaries. Soon, lay summaries are likely to become mandatory for all clinical studies. The European Union Clinical Trials Regulation 536/2014 already includes a requirement for submission of lay summaries, which will be applicable once the EU clinical trials database and portal become fully operational. Recommendations for the development of these lay summaries have been made available.
Developing such a document can be challenging for professionals in the pharmaceutical industry who are used to write for an audience with high health literacy and a considerable amount of background knowledge. Translating the scientific information to the general public requires much more than just using simple words and shorter sentences. Relevant information for patients and the general audience should be presented in an understandable way, without over-simplification, and additional context may need to be given to allow the lay reader to understand what the presented information means to them individually. For example, patients are often unaware of the lengthy timelines in drug development; a positive outcome of an early-phase clinical study could make them believe that the tested drug will soon be available to them. Adding figures and infographics, and proper use of formatting (e.g. bullet lists, colours) can help to make the document easier to digest. Finally, the document should be kept short, which can be challenging as explaining scientific terms in an understandable way often requires additional words.
Support by a medical writer with experience in lay summaries can be very valuable to help translate scientific data to the general public. At Modis we provide experts who can help your company reach its communication goals.
Joke Vandewalle
Scientific and publication writer, knowledge sharing coach
Life Sciences