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Sharing Clinical Trial Results with Pediatric Participants

17 January 2022

Sharing results with paediatric trial participants and the general paediatric community at large in an age-appropriate manner is an area with limited practical guidance and limited literature on practices to date.

To better understand what might work for a paediatric audience and learn more about the preference for the “plain language summary” (PLS) by children and young people, a small survey was conducted by involving members of eYPAGnet and KIDS Barcelona (ages 12-19).

The results of this survey indicated a preference for the PLS to be in video format, most indicated additional preferences, including infographics, written reports with charts and graphs, or in a comic or story book style. Though multiple design formats may be complicated and costly, especially within six months of trial completion as the regulation requires, this should be considered a best practice if the end goal is to ensure comprehension for all ages included. This takes forethought and planning much earlier than what is the norm and is more complex in the paediatric space to ensure input from all ages of participants.

Sponsors should also consider co-creation with paediatric participants, with an earlier involvement during the protocol design stage preferred. However, at minimum, sponsors should involve paediatric participants in the review of a PLS to ensure readability and value of the final document. 

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