Implementing Good Lay Summary Practice

The upcoming Clinical Trial Regulation requires the development and dissemination of Lay Summaries of clinical trial results from commercial and non-commercial sponsors.

Over 60 participants from EU and US pharmaceutical companies, CROs, academic institutions, patient organisations, and not-for-profit organisations have created the “Roadmap Initiative to Good Lay Summary Practice” with the aim to develop a pragmatic, broadly accepted framework for Lay Summary planning, development, translation and dissemination. Building on experience and documents that are already available, this Roadmap Initiative created a draft guideline based on the work and pragmatic solution proposals of 5 multistakeholder Task Forces. After integration of the comments from a broad public consultation the draft recommendations were further developed together with The European Commission’s Expert Group on Clinical Trials (CTEG). In July 2021 the final text was adopted by CTEG and on 04 October 2021 the European Commission published the “Good Lay Summary Practice Guideline” in EudraLex Volume 10. To ensure that suitable Lay Summaries become reliably available to patients and the public the Roadmap Initiative to Good Lay Summary Practice decided to jointly work on the second important step: the implementation of this standard in the collaboration between all involved stakeholders. This requires broad awareness about this new standard and multi-stakeholder discussion about expected hopes and hurdles for its implementation. Jointly worked-out proposals for most suitable and needed implementation activities need to be developed now.

In this virtual 3 afternoons Workshop the key content of GLSP will be presented and hopes and hurdles for its implementation raised on Day 1. On Day 2 participants will be able to join 2 out of 4 Break-out Sessions of their choice in which concrete proposals will be worked out on how best to prepare our communities for the respective particularly challenging aspects of GLSP. On Day 3 the results from these Break-out Sessions will be presented, jointly discussed and conclusions proposed to inspire the European Commission’s and the Roadmap’s second important objective: the implementation of GLSP in clinical research daily practice including training opportunities for all involved stakeholders.