Good Lay Summary Practice

The European Commission (EC) has published a guideline on "Good Lay Summary Practice" (GLSP). The guideline was adopted by the Clinical Trials Expert Group (CTEG) of the EU Commission, which is composed of representatives of ethics committees and national competent authorities.

GLSP - What´s in

The GLSP provides recommendations for preparing and writing summaries of clinical trial results. It also describes how these should be translated and published in language understandable to lay people (including user testing). This is in line with the requirements under Article 37 of Regulation (EU) No 536/2014 on clinical trials (Clinical Trials Regulation, CTR). Article 37 of the CTR requires sponsors to submit a lay summary (LS) for each clinical trial involving medicinal products included in the EU Clinical Trials Database (part of the Clinical Trials Information System, CTIS, available from January 31, 2022). The LS must be submitted to CTIS generally no later than 12 months after the protocol-defined end date of a clinical trial. For pediatric trials, the deadline is shortened to six months, and for non-therapeutic Phase 1 trials, it is extended up to 30 months.

The content of the LS is set out in Annex V of the CTR. It shall contain information on the following elements:

• Clinical trial identification (e.g. title of the trial, protocol number, EU trial number, other identifiers);
• Name and contact details of the sponsor;
• General information about the clinical trial (e.g. where and when the trial was conducted, the main objectives of the trial, explanation of the reasons for conducting it);
• Population of subjects (e.g. number of subjects, age group and gender breakdown, inclusion and exclusion criteria);
• Investigational medicinal products (IMPs) used;
• Description of adverse reactions and their frequency;
• Overall results of the clinical trial;
• Comments on the outcome;
• Follow up clinical trials;
• Additional information.

More information is available in Good Lay Summary Practice published in EudraLex - Volume 10 - Clinical Trials Guidelines.