In October 2021, the European Commission (EC) released the Good Lay Summary Practice (GLSP) Guidance. This document is organised in two parts (Part 1 a Quick Guide and Part 2 the full GLSP Handbook) and provides recommendations on how to prepare, write, translate, and disseminate summaries of clinical trial results in lay language. This is a mandatory requirement recently laid out in the Clinical Trials Regulation, Regulation (EU) No. 536/2014, and a transparency obligation to all trial participants and the interested public.
In particular, the GLSP recommends clinical trial sponsors to organise the lay summary process (“LS process”) in four steps: planning, development, translation, and dissemination (see figure below).