Lay Summary

A Lay Summary (also referred to as layperson summary, trial results summary, plain language summary, simple language summaries, …) is a summary of the Clinical Study Report in plain language, ie, a summary understandable to a layperson, to be uploaded on a publicly available clinical trial register. The purpose of the Lay Summary is to aid trial participants and the general public in understanding clinical trial results and to provide greater transparency.

The Lay Summary is mandatory in the EU following Regulation (EU) 536/2014. Posting the Lay Summary on a public portal should be done within 1 year after completion of the trial (or within 6 months after completion of a pediatric trial). Currently, the United States FDA does not require lay summaries of clinical trial results to be publicly disclosed (although it is encouraged). However, in line with the plain writing act of 2010, federal agencies in the United States should use clear government communication that the public can understand and use. Several pharmaceutical companies are already disclosing lay summaries on company websites or public websites gathering such lay summaries.

The language used in the Lay Summary should be non-scientific, non-technical, and easy to understand for the general public (and/or the specific patient population in the clinical trial). Well-chosen and clearly designed visual aids and graphics can be used to enhance the accessibility and understanding of the content by the target audience. It is good practice to include laypersons in the review/development of this document.

Per Regulation (EU) 536/2014, the Lay Summary includes the following elements: clinical trial identification; sponsor name and contact details; general clinical trial information; population of subjects; investigational medicinal products used; description of adverse reactions; overall results; comments on clinical trial outcome; indication if follow up clinical trials are foreseen; indication where additional information could be found.

Generally, the Lay Summary is generated once when the final Clinical Study Report is generated and is not updated. However, Lay Summaries could also be developed for interim analyses (eg, for trials with a long-term, open-label extension within the same protocol). For such trials, the delivery of an interim Lay Summary may be of great value to trial participants. Consequently, such interim Lay Summary would need to be updated with final results after trial completion.

The Emtex Medical Writer can help you with the document development process (eg, writing, circulating for review, implementing comments), after or during development of the Clinical Study Report. It is important to align the descriptions and terminology between the Informed Consent Form and the Lay Summary.