European Regulators Offer Recommendations on Release of Trial Summaries

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The European Commission (EC) has released extensive recommendations for sponsors covering best practices for the development, translation, and distribution of lay summaries of clinical trial information, intended both for trial participants and the general public.

The EC’s Clinical Trials Expert Group adopted the guidelines in July 2021 and released them in early October. The 85-page document guides users through the lay summary process from the planning and scoping stage, through the development process, to testing translations, and final dissemination to intended audiences.

The lay summary gives sponsors a framework to fulfill their legal commitments under EU Regulation 536/2014 Article 37, which requires them to file lay summaries of all pharmaceutical trials into the Clinical Trials Information System.

The new document provides a quick guide as well as a more detailed Good Lay Summary Practice handbook.

Edited by Michael Causey