Plain language summaries of clinical trial results: What is their role, and should patients and AI be involved?

Plain language summaries (PLSs) of clinical trial results are vital tools in the clinical development process for enhancing transparency and encouraging and facilitating patient engagement. The production of a PLS is now mandated in the EU for all interventional clinical trials by the European Medicines Agency under Regulation EU 536/2014 and became compulsory with the opening of the Clinical Trial Information System portal in January 2022. PLSs are intended to be accessible, comprehensible documents conveying complex trial findings to diverse audiences. This article explores the significance of PLSs, the importance of patient input in their production, and the role and concerns surrounding the use of artificial intelligence in generating them.