To date, those who develop and trial medicines have not been obliged to report the results to trial participants and the public, once a trial is completed. This lack of transparency will be a thing of the past, from the second half of 2020 onwards.
To this end, a “Roadmap Initiative to Good Lay Summary Practices” has been put in motion by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Forum for Good Clinical Practice (EFGCP).
This Roadmap, which is being drafted through 2019 by representatives from academia, industry, and patient engagement, is tackling the following topics:
- the principles and processes of Lay Summary implementation beyond existing guidances;
- competencies required for developing and translating the lay summaries;
- dissemination, including technologies, of the summaries within and beyond the European Medicines’ Agency (EMA) portal;
- suitable processes and technology to reach patients, the health-interested public, and healthcare professionals;
- issues related to creating, translating, and funding the dissemination of the summaries, particularly for academia and small-to-medium enterprises; and
- matters of pertinence to paediatric clinical trials.
The Clinical Trial Regulation EU 536/2014, which is set to come into effect in the second half of 2020, requires that a lay summary of trial results be disseminated in accessible language within 12 months after the end of the study and even earlier, within 6 months, for paediatric trials. Such feedback will give patients better, more understandable, and reliable access to the results of clinical trials. General awareness about this progress is low, not only among commercial and non-commercial sponsors (who will have to produce these lay summaries), but also among patients and patient organisations.
The EFPIA and EFGCP began preparing in 2015, in anticipation of these changes. The Roadmap underway builds on this foundation.
The SCTO is contributing to this process and will keep our readers informed, as this development is of importance to Switzerland.