Two recent publications are helping to increase the profile of clinical trial lay summaries, drawing attention to important considerations for their development.
The first highlights the importance of a good title for clinical trial lay summaries. The second provides specific direction for medical writers, who will often be tasked with developing these documents. The abstracts are available below, alongside links to the articles.
Lay titles for clinical trials: A balancing act
With increasing transparency demands and the new legal requirements for providing clinical trial information to lay readers, clinical trials need to be given titles that patients can understand and recognise. Trial titles inform the readers what the trial is about, what substances are studied, and who the target population is. Devising a lay title is challenging as it needs to be understandable to lay readers, fully identify the trial, meet registry requirements, and also be translatable into different languages. Lay titles also need to fit different types of documents, e.g. trial protocols, trial advertisements, informed consent forms, and lay summaries. As the lay title is one of the first pieces of information that is displayed, good lay titles help patients searching clinical trial registries for trial participation. For sponsors, informative and understandable lay titles increase the chances of attracting the target patient populations for clinical trials.
Writing lay summaries: What medical writers need to know
Lay summaries are critical for building public trust in clinical research and therefore for recruiting patients. They are also an important part of efforts to improve data transparency. Due to new global regulations, lay summaries will soon probably become mandatory for all clinical studies. Medical writers should therefore be aware of the regulations and essential content of lay summaries. Using a case study of a published lay summary, this article discusses best practices, including the appropriate target audience, language, and data and visual presentation.