Award-winning summary of clinical trial results for pediatric participants with diabetes

May 20th is International Clinical Trials Day. We are marking the day by celebrating a major achievement at HLM, as the 2026 Grand ClearMark Winner for a clinical trial results lay summary for teens and young adults!

The ClearMark Grand Prize was given to HLM and our partner for an English-language pediatric results summary of a diabetes trial. We also received the ClearMark Category Award for Lay Summaries for this work, and the French Category Award for the French-language version. This achievement came out of a collaboration with one of HLM’s longtime pharmaceutical partners.

Here's what some of the judges had to say about the summary:

"This is a great example of plain language. The sentences are short and have common words. The tone makes it clear that you are speaking to young people. It puts it in their words without being condescending."

"I’m so impressed with the evaluation efforts on this entry! Wow. Great job regularly testing the content with your target audience and updating it accordingly."

"The organisation and layout are clear, logical and accessible. The reader is not overwhelmed by too much information – this is a good example of careful editing."

"The language and tone are appropriate for the intended audience. The visuals are well thought out and they actually perform work that helps the reader understand the overall message. The flow diagram explaining how sugar is processed is a very good example of effective communication."

The challenge

The European Union Clinical Trial Regulation requires that trial sponsors publish a summary of trial results that is understandable to a lay person. However, for trials with children, there are no specific standards or requirements for how to make lay summaries age-appropriate and understandable. As a result, pediatric lay summaries are often misaligned with children’s developmental stage and attention span and lack an engaging format.

The diabetes trial

The purpose of the trial was to learn about the effects and safety of a trial drug for children and young adults with newly diagnosed type 1 diabetes. The trial drug is created to keep the pancreas making insulin. The trial had 44 participants aged 12 to 21. Participants were from 6 European countries: Belgium, Germany, Italy, Slovenia, Spain, and the United Kingdom.

Making the pediatric summary

After publishing a summary of results for adult readers (such as the parents and guardians of the participants), HLM created the pediatric summary for the teens and young adults who were in the trial using an engaging and easy-to-understand format, including:

• Visual aids such as illustrated characters, diagrams, stories, large font, and colors to engage and resonate with young participants

• Simple language that aligns with how teens talk

This cover page from the summary shows how we used these approaches to introduce the trial, thank participants, and describe the trial’s primary endpoints:

This page shows how we used the illustrated characters, bright colors, large font, and a diagram to show who was in the trial:

Doing audience testing

We tested the summary in virtual interviews to gather feedback on it from children with diabetes and their parents. We interviewed 4 parents of children with type 1 diabetes. Each parent read the summary with their child before the interview. One child also participated in an interview. HLM used a structured interview guide to get the parents’ and the child’s impressions and understanding of the summary.

From the feedback, HLM made 2 key revisions to the summary:

• We added a pronunciation key for the word “placebo” because parents shared that their children didn’t know the word or how to say it

• We removed the technical name of the primary endpoint measure, which was “mixed meal tolerance test” because children did not understand it. We replaced it with “liquid meal” and a description of the test.

These pages show the content after we edited from the feedback:

Translating the summary

We partnered with a translation company to translate the summary into 6 other languages (Dutch, French, German, Italian, Slovenian, and Spanish), so all participants can read in their primary language. Each translation was reviewed by local native speakers from that country. Belgian French has influences from Dutch, German, and other languages that distinguish it from French spoken in France. So this local review ensured it used language familiar to teens and young adults in French-speaking Belgium. This what the first page of the Belgian French version looked like:

Looking forward

Winning the 2026 ClearMark Grand Prize was a huge honor for HLM. We look forward to continued partnership to ensure pediatric trial materials are understandable and engaging for children around the world!

See the 2026 ClearMark award winners here.