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Call for Interest - Roadmap Initiative on Lay Summaries of Clinical Trials Results

The EU Clinical Trial Regulation will come into application in the second half of 2020. It requires the development of a lay summary of the results within 12 months after the end of the study (in paediatric trials within 6 months), which will be published on the electronic EU clinical trials portal.

EPF has worked with EFGCP and EFPIA on the topic of lay summaries in the last years, and we participated in a working group that developed EU Guidelines on summaries of clinical trial results for laypersons, published by the European Commission.

Discussions have revealed that there is not yet enough awareness amongst clinical trial sponsors – both commercial and non-commercial – and amongst patients/patient organisations about the future obligation to communicate study results in lay language. Issues to tackle include the knowledge gap as well as the principles, development processes and practical implementation of lay summaries.

EPF is participating in the “Roadmap Initiative to Good Lay Summary Practices”, led by EFGCP and EFPIA, to find a systematic approach to implementing the lay summaries and making them “real” by the time the CTR comes into application. 

Five task forces

The core group of organisations met on 22 January and identified five areas of particular complexity require detailed discussions and solutions, so five task forces have been set up. For each one, we are looking for patient representatives who would be interested in participating.  

  1. 1.      Principles and processes of lay summary implementation beyond existing guidances

This group will take into account all existing recommendations and prepare a guidance/recommendations document describing what aspects need to be considered in the whole process and offering pragmatic solutions. Patient involvement and how to embed that in the process will be a core concern. 

  1. 2.      Competencies required for development and translation of lay summaries

This group will identify, discuss and agree on recommendations concerning the competences (knowledge, skills, attitudes) and suitable backgrounds for persons preparing and translating lay summaries. It will also consider the roles of patients and patient organisations. Translation issues will include cultural adaptations.

  1. 3.      Lay summary dissemination

This group will work out which dissemination, storage and access pathways exist and how best to use them to ensure broad usage of information from lay summaries, including the EMA clinical trials portal and EUDAMED, but also beyond those. Findability will be a key concern. 

  1. 4.      Funding issues related to lay summary creation, translation and dissemination, particularly for academia and SMEs

This group will work out the financial implications of lay summary development and dissemination, especially for small enterprises as well as publicly sponsored studies, and suggest solutions. Funding for patient organisations could be considered in this group.

  1. 5.      Suitable technologies to reach patients, the health-interested public, and healthcare professionals

This group will identify needs and develop recommendations for suitable technical solutions to lay summary dissemination and attractive use of lay summary information in today’s and future world of social media, and consider how patients and members of the public interested in clinical study results access and use information.

Looking for interested patient representatives

We are looking for patient representatives who are interested in participating and willing to contribute their knowledge and experience to help define the Roadmap. One person should ideally join only one task force, but please let us know if you are interested in more than one.  

Workload will vary according to time and interest, but participants are expected to attend teleconferences/virtual meetings and contribute to discussions and drafting of the documents, as agreed internally in the task force. Each task force will have two co-chairs, one of whom will be a patient representative.

There is no compensation available per se for participation, but in case of face-to-face meetings, reasonable travel and accommodation costs of patient representatives will be covered.

Indicative timeline

-          Kick off meeting in Brussels, 11 March 2019 (10:30-16:00)

-          Task forces will work between March and November 2019

-          Joint workshop will present and discuss draft results in December 2019

-          Integration of workshop results into the different “deliverables” by February 2020

-          Extended public consultation in March-April 2020

-          Consolidation of feedback and production of final outcomes for release in July 2020.

If you are interested?

Please contact EPF at policy@eu-patient.eu ideally by 15 February to let us know if you are interested in one of the task forces! You can also email us if you have questions or need more information. If you are interested in more than one group, please indicate which is your preference. Also please let us know if you are willing to be co-chair! The core group will reserve the right to propose people to different task forces to ensure balanced representation, and we will contact you to discuss and confirm your participation. 

Thank you!