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 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. For this reason a group of 60 participants from EU and US pharmaceutical companies, CROs, academic institutions, patient organisations, and not-for-profit organisations under the leadership of the European Forum for Good Clinical Practice (EFGCP) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) has created the “Roadmap Initiative to Good Lay Summary Practices”. The TEDDY Network took part in the group which intended to develop a pragmatic, broadly accepted framework for Lay Summary development, content and dissemination. In this context, a draft guideline was released and was object of a Public Consultation. The role of the TEDDY Network was to underline the necessity to pay more attention to paediatric population which has the rights to be informed in a proper way according their age for the results of the paediatric clinical trials. Moreover, TEDDY encouraged the involvement of the paediatric population in all the phases of Lay summaries development for obtaining a children-friendly document.
More information about the initiative is available here.
