Joint EFGCP & EFPIA Workshop

The upcoming Clinical Trial Regulation requires the development and dissemination of Lay Summaries of clinical study results from commercial and non-commercial sponsors. Several large companies have already generated experience with creation of Lay Summaries and in the USA guidance on Lay Summary content have already been developed.
Also, EMA has released an Expert Group Recommendation on the content of Lay Summaries. However, there is no guidance for all types of sponsors on how best to handle the development process of Lay Summaries and how best to ensure reliable dissemination so that the ultimate goals can be achieved: increase of clinical research transparency, patients’ and public’s understanding of clinical research as well as feedback to study participants about the results of their study.
To create a suitable, mutually acceptable framework for Lay Summaries a consorted effort of all involved stakeholders is required.
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 Practices” with the aim to develop a pragmatic, broadly accepted framework for Lay Summary development, content 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 multi-stakeholder Task Forces.

In this one-day workshop the draft guideline resulting from the work of these 5 Task Forces will be presented and topics that are particularly controversial or difficult to decide will be presented and discussed with the multi-stakeholder audience before a final draft will be released for broad public consultation.