New Roadmap Initiative tackles practical challenges of creating lay summaries of clinical trial results

The EU Clinical Trial Regulation (Regulation EU No 536/2014) came into force on June 2014, and will be applicable by the second half of 2020. The exact timing of this depends on the development of a functional EU clinical trials portal and database, managed by the European Medicines Agency.

One of the landmarks of the new Regulation will be that all clinical trials must be registered in the EU portal and, a year after a trial finishes, its results must be made public along with a “lay summary” for non-experts.

EPF was actively engaged in the drafting of the new EU rules, and particularly on the importance of transparency of clinical trial results. Effective communication of scientific research to patients and the public, as we stated in our position paper in 2015, is a vital requirement of an open, inclusive and accountable system. We subsequently took part in a working group headed by the UK Health Research Authority, which developed an EU guideline for the drafting of lay summaries.

Nevertheless, discussions with different stakeholders have revealed there is still a lack of awareness amongst both commercial and non-commercial sponsors as well as patients and patient organisations about the lay summaries requirement, and several practical issues remain unclear.  

A group of concerned stakeholders met in Brussels in January to set up a “Roadmap Initiative to Good Lay Summary Practices”. This initiative, headed by the EFGCP[1] and EFPIA[2], aims to develop a systematic and practical approach to implementing lay summaries. EPF is part of the core group of organisations involved, together with ECRIN[3], EORTC[4], AGAH[5], Boehringer Ingelheim, and AstraZeneca. In response to a call for interest, several patient representatives agreed to participate in the group process.

In its first meeting, on 11 March, the Roadmap initiative consolidated five task groups, which will be addressing specific challenges and solutions:

  1. Principles and processes of lay summary implementation, beyond existing guidance
  2. Competencies required for people developing and translating lay summaries
  3. Lay summary dissemination within and beyond the EMA portal and EUDAMED
  4. Financial issues relating to lay summary creation, translation and dissemination, particularly for academia and SMEs
  5. Suitable technologies to reach patients, the health-interested public and healthcare professionals

The groups will present and discuss their draft work in a workshop foreseen to take place in Brussels in December 2019. The work will then be integrated and finalised in early 2020, followed by a public consultation period, so that a consolidated document will be published in mid-2020.

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[1] European Forum for Good Clinical Practice

[2] European Federation of Pharmaceutical Industries and Associations

[3] European Clinical Research Infrastructure Network

[4] European Organisation for Research and Treatment of Cancer

[5] Association for Applied Human Pharmacology