The upcoming Clinical Trial Regulation requires the development and dissemination of Lay Summaries of clinical study results from commercial and non-commercial sponsors. 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.
To this aim, over 60 participants from EU and US pharmaceutical companies, Contract Research Organisations (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.
The draft guideline resulting from the work of these 5 Task Forces has been presented during the Workshop “Roadmap Initiative to Good Lay Summary Practices”, Framework Proposal for development and dissemination of results from commercial and academic studies, organised by the European Forum for Good Clinical Practice – EFGCP and the European Federation of Pharmaceutical Industries and Associations – EFPIA on 15 January in Brussels.
The meeting was also the occasion to discuss topics that are particularly controversial or difficult to decide with the multi-stakeholder audience before a final draft will be released for broad public consultation.
TEDDY Network was among the several multi-stakeholder contributors of the meeting, being involved in the Lay Summary Paediatric Task force. Moreover, the young members of KIDS Bari and KIDS Albania have provided their contribution in the revision and assessment of the lay summaries used in paediatric clinical studies. The children evaluated the readability, the glossary and the format of the documents to make them more accessible to paediatric population.
For further information about the meeting, please click here.