From 1 June 2016 to 31 August 2016 the Directorate General for Health and Food Safety, DG SANTE launched a public consultation with the aim to seek the views of stakeholders and other interested parties, on the “Summary of Clinical Trial Results for Laypersons”, which has been developed by the expert group on clinical trials in preparation for the implementation for the Clinical Trials Regulation (EU) No 536/2014.
According to Article 37 of the Clinical trial Regulation (EU) No 536/2014, sponsors are required to provide a summary of clinical trial results in the EU Portal and Database, in a format understandable to laypersons.
The main objective of this document is to provide recommendations and templates for the production of a summary of clinical trial results for laypersons by sponsors and investigators, in accordance with Annex V of the EU Clinical Trials Regulation.
In particular, the document provides detailed information about the health literacy level to consider in the summary, readibility, specifying the size of the serif font and some examples of summary, suggesting a wording more comprehensible for the target population. Despite not mandatory, this document intends to make the summaries more accessible to the lay person.
TEDDY participated in the public consultation, proposing to include paediatric specificities in the consultation document by adding a paediatric paragraph and specific reference to the paediatric population as well as to develop laypersons summary in age appropriate, simple and understandable language to ensure easy reading by parents and by children.
We are pleased to inform you that a whole paragraph dedicated to paediatrics, including the TEDDY proposal, has been added into the final version of the document.
The TEDDY proposal is available here.
A summary of the responses is available here
The recommendations of the clinical trials expert group on the Summaries of Clinical Trial Results for Laypersons, January 2017 (Chapter V) have been published in Eudralex Volume 10, Chapter V and is availble at this link: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/2017_01_26_summaries_of_ct_results_for_laypersons.pdf