GLSP

Initiative leader: EFGCP & EFPIA

Duration: March 2019 - January 2022

In March 2019, the EFGCP, together with EFPIA, established an international multi-stakeholder group to identify best practices for the delivery of a fit-for-purpose Lay Language Summary (LS) of clinical study results, building on an existing guidance issued by the European Commission guidance in 2017. The LS working group consisted of experts from over 60 academic organisations, the pharmaceutical industry, patient organisations, and not-for-profit organisations and set up the Roadmap Initiative to Good Lay Summary Practice (GLSP). Its objective was to develop and issue a framework guidance document detailing the planning, development, translation, and dissemination of LSs of clinical trial results as required by the 2014 EU Clinical Trials Regulation (CTR No 536/2014).

The GLSP Roadmap Initiative worked continuously over 2.5 years, building on the experience of public and private sponsors across and beyond Europe, input from patient representatives and valuable support of the CTEG. The result was a 85-page comprehensive guidance document including a quick guide to help sponsors. Importantly, the framework recognises that patient involvement, resources, and LS translations are challenges especially for academia.

The Good Lay Summary Practice (GLSP) Guidance was adopted by the Expert Group on Clinical Trials (CTEG, a working group of the European Commission consisting of representatives from Ethics Committees and National Competent Authorities and EMA) and subsequently published on 4th October 2021 in EudraLex Volume 10. For promoting the implementation of the GLSP guidance, several workshops and training sessions had been organised.

ECRIN's Role in Good Lay Summary Practice

ECRIN contributed as academic stakeholder to the GLSP framework development, considering the academic view, requirements and challenges.