On 15 January 2020, the EFGCP & EFPIA Workshop “Roadmap Initiative to Good Lay Summary Practices” will be held in Brussels. The upcoming Clinical Trial Regulation requires the development and dissemination of Lay Summaries of clinical study results from commercial and non-commercial sponsors. 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. To create a suitable, mutually acceptable framework for Lay Summaries, 60 experts from 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. Also TEDDY Network provided this contribution in this working group and will be represented by Donato Bonifazi and Mariangela Lupo in the next one-day workshop, when draft guideline will be presented and topics that are particularly controversial or difficult to decide will be discussed with the multi-stakeholder audience before a final draft will be released for broad public consultation.
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