Communicating with children and their families: Engaging patient expert feedback and new media approaches to improve paediatric informed consent forms and lay summaries

Communicating clinical trial information to the public is inherently challenging, given the complexity of medical terminology, procedures, and risks. This challenge is magnified when explaining clinical trials to children, who require clear, age-appropriate information to understand their participation. It is an ethical imperative to ensure that children and their families are fully informed about the trials in which they are involved.

At Boehringer Ingelheim, we have implemented several strategies to address this issue. One effective approach is the use of a paediatric expert advisory board. This board reviews our informed consent forms for children (called “assent forms”) and provides valuable feedback, enabling us to refine these documents to be more comprehensible for young participants. Additionally, we have embraced new media solutions, such as comics and videos, to make informed consent forms and lay summaries more engaging and accessible for children.

In our workshop session, we will present aggregate results from the paediatric advisory board’s feedback. We will highlight specific areas of the assent forms that have been updated and improved based on this feedback. Furthermore, we will showcase examples of our paediatric comics and videos, which have been used to explain trial results in a child-friendly manner.

Participants in the workshop will have the opportunity to discuss and explore other industry approaches to enhancing the clarity and accessibility of clinical study information for children and their families. This session aims to foster a collaborative environment where medical writers can share best practices and innovative solutions for improving paediatric clinical trial communication.

Karen Hinkle, Boehringer Ingelheim, USA

Dr. Karen Hinkle has been a medical writer with the Lay Language & New Media team at Boehringer Ingelheim for 2.5 years. Previously, she was a biology professor, researcher, and administrator at Norwich University, a comprehensive liberal arts academic institution in Vermont, USA. It was as a biology professorship where Karen’s passion for deconstructing technical information to plain language was born. At Boehringer, Karen continues this work through developing regulatory plain language documents for clinical trials, including lay summaries, informed consent forms, paediatric assent forms, lay protocol synopses, brief summaries, and others. She also oversees the development of the company-wide plain language glossary. Karen is an active member of AMWA and presented information about the glossary at the national conference in October, 2024, in New Orleans, LA, USA.

Sebastian Florescu, Boehringer Ingelheim, Germany

Dr. Sebastian Florescu is also a Lay Language & New Media Medical Writer at Boehringer Ingelheim, where he has worked for about 4 years. With a PhD in cancer biology from the German Cancer Research Institute, Sebastian combines his scientific expertise with a passion for plain language writing and visual communication. He authors lay regulatory documents, including brief summaries, lay protocol synopses, informed consent forms, and lay summaries of study results. Sebastian is dedicated to making complex scientific information accessible and engaging for patients and the public. He also supports the development of digital solutions that enhance clinical development and communication. An active member of EMWA, Sebastian is committed to improving the clarity and accessibility of clinical trial information through innovative approaches.