The Roadmap Initiative
The Roadmap Initiative to "Good Lay Summary Practice" is co-led by EFGCP and EFPIA, bringing together stakeholders involved in Lay Summary development and dissemination.
First WorkshopFirst joint EFGCP-EFPIA Workshop in collaboration with US colleagues to identify requirements for Lay Summary development.
Second WorkshopSecond joint EFGCP-EFPIA Workshop to review the new Lay Summary content guideline and identify gaps for reliable improvement of clinical trial result transparency
The Roadmap Initiative EstablishmentDecision by EFGCP and EFPIA to jointly establish a Roadmap Initiative to Good Lay Summary Practice.
Task Forces CreationKick-off Meeting of the new Roadmap Initiative together with US colleagues, formation of 5 Task Forces, co-led by a patient representative. Multi-stakeholder discussions and decision to create a framework for Lay Summary planning, development, translation, and dissemination, a new best practice standard.
Third WorkshopThird joint EFGCP-EFPIA Workshop to discuss the developed GLSP content with a broader public. Refinement of the draft and release of a broad public consultation on the DRAFT GLSP guideline. Proposal to European Commission DG Santé Unit B4 to jointly further develop this draft to an official EU guideline.
CTEG Adoption2 rounds of proposals, review, negotiations and finally adoption of the agreed text by CTEG, the European Commission’s Expert Group on Clinical Trials, publication of the guideline on 04 October 2021 in EudraLex Volume 10. Decision of the Roadmap Initiative Members to continue the Initiative into the Second Phase: the implementation of this GLSP framework.
Fourth WorkshopFourth joint EFGCP-EFPIA Workshop to learn about needs, expectations and options for reliable implementation of the GLSP from expert representatives of all stakeholders including EMA and the European Commission.
Core Management Team
Co-Leaders of the Task Forces and invited experts
: GLSP Development
Task Force 1
Development of the GLSP Guideline
Task Force 2
Competencies required for Development and Translation of Lay Summaries for Patients and all other Stakeholders
Task Force 3
Lay Summary Dissemination within and beyond CTIS
Task Force 4
Enabling GLSP in Academia/Publicly funded Studies
Task Force 5
Lay Summaries for Paediatric Studies
: GLSP Implementation
Task Force 6
GLSP Website Development
Task Force 7
Task Force 8
Task Force 9
Task Force 10