Strong EUPATI Presence at Roadmap Initiative to Good Lay Summary Practices Meeting
Having participated in a clinical trial in the past, I found it difficult to get access to the results in an understandable format. This is an issue for many patients who have either taken part in or would like to know the outcomes of a particular trial. The Clinical Trial Regulation EU 536/2014 will come into effect in the second half of 2020. It requires the dissemination of a Lay Summary within 12 months after the end of the study and within 6 months in paediatric trials. This will give patients better, understandable, and reliable access to the results of clinical trials that might change their lives and allow them to disseminate this information within their communities.
Based on conclusions from 2 previous EFGCP-EFPIA Workshops on Lay Summaries in 2015 and 2017 and the “EU Guidelines on Summaries of Clinical Trial Results for Laypersons” discussions, the involved stakeholders decided that there is not yet enough awareness amongst commercial and non-commercial sponsors as well as patients and patient organisations about the future obligatory communication of study results in lay language.
Generally, there is a large knowledge gap concerning the required principles, optimal development processes, and practical implementation aspects resulting from the new legislation in the involved communities. A group of concerned stakeholders met in Brussels on 22 January 2019 to create a “Roadmap Initiative to Good Lay Summary Practices” to find a systematic approach to introducing the infrastructure required to ensure that Lay Summary development and dissemination can be reliably handled by the non-commercial and commercial sponsors and involved patients and will enable the expected valuable level of transparency. The scope of clinical studies to be covered by this future Lay Summaries infrastructure will focus on clinical trials with medicines but its principles will go beyond this and will include all types of clinical studies. The group consisted of representatives from EFGCP, EFPIA, EPF, ECRIN, EORTC, EUPATI, EATG, AGAH, Boehringer Ingelheim, and AstraZeneca. This Core Management Team (CMT) invited organisations in academia, industry and patient engagement to join the Initiative.
The first step in the Roadmap Initiative was the multi-stakeholder gathering of all parties that had responded to the CMT’s call, on March 11th, 2019, in Brussels. In this meeting 6 areas of complexity were identified that require detailed discussion and solution finding in dedicated Task Forces working closely with the CMT:
- Principles and processes of Lay Summary implementation beyond existing guidances
- Competencies required for development and translation of Lay Summaries
- Lay Summary dissemination within and beyond the EMA Portal and EUDAMED
- The issues of Lay Summary creation, translation and dissemination funding, particularly for academia and SMEs
- Suitable technology to reach patients, the health-interested public and healthcare professionals
- Issues specific to paediatric clinical trials
About 30 individuals attended on the day and many others dialled in. EUPATI fellows included Julie Deléglise, Estelle Jobson, Joan Jordan, Marleen Kaatee, Lotte Klim, Souzi Makri, Begonya Nafria and Margit Paul. Everyone who attended the meeting was interested and willing to contribute their knowledge, experience and commitment to help defining the Roadmap and jointly working out pragmatic and reliable solutions in one or several of these 6 Task Forces.
The following timeline is planned for the new Initiative:
- Identification of gaps and hurdles as well as solution development within the Task Forces between March and November 2019
- Joint Workshop to present and discuss draft results in December 2019
- Integration of Workshop results into the different deliverables until February 2020
- Extended public consultation in March and April 2020
- Consolidation of feedback and production of final outcomes for release in July 2020
This initiative will help to provide our community with concrete recommendations and hopefully improved infrastructure in time before we will start to work according to the Clinical Trial Regulation and will raise broader awareness about the need to implement the Lay Summary process and its implications in Europe. Everyone at the meeting provided valuable input and the patient’s voice was strongly represented. It is important for all patients and patient organisations to be aware of this new transparency opportunity to achieve an environment in which patients and the public are objectively and reliably informed about clinical study results in lay language.