EMA Clinical Trials

As you know, EPF has been working with a multi-stakeholder group since 2019 on a new guidance document to facilitate the production of lay summaries of clinical trials. Publication of lay summaries along with the comprehensive summary results is a requirement under the new EU Clinical Trials Regulation. EPF published our position paper on this topic in 2015.

We are pleased to share the final draft of the new Recommendations for Good Lay Summary Practices, which is now undergoing a public consultation until 14 September 2020.

Feel free to disseminate this document to your networks, and submit comments through the following web link.

 Through the link you can access two documents:

1. The Recommendations document for your review (PDF)

2. A template to submit your comments (Word)

Please send any comments you may have using the template to [email protected]

Next steps:

  • The multi-stakeholder group will review and integrate feedback from the public consultation during September-October
  • We expect to finalise the document soon afterwards and release it in December 2020.