Patient centricity and transparency are increasingly important topics in the area of clinical trials. One element of these conversations, backed up by recent regulatory requirements such as EU Regulation 536/2014, is creating a plain language summary (PLS), also referred to as a lay summary. A PLS provides transparency and factual, reader-friendly summaries of research for participants and the public, typically written at a reading level accessible for anyone 12 years and older.
However, one important demographic is often left out of conversations about creating a PLS: children, technically defined as ages from birth to under 18 years of age. Participants in paediatric studies are often under the age of 12, which means they may not understand a typical PLS. So the question remains: How can sponsors create a PLS that is better understandable to paediatric audiences?
Good Lay Summary Practice Guidelines
In October of 2021, the Clinical Trials Expert Group, a working group of the European Commission, adopted a set of recommendations entitled Good Lay Summary Practice (GLSP). As the name suggests, these recommendations outline best practices for creating a PLS, which meets regulatory requirements and accomplishes its purpose of accessibility to public audiences.
To help guide the creation of a PLS, the GLSP breaks down child audiences into groups categorised by age: 8 or under; 9 to 11; and 12 to 17. Helpfully, several charts are included, which note possible approaches to messaging and presentation appropriate to different levels of comprehension. For example, it suggests that a PLS for children eight or younger should primarily use pictures and cartoons, providing text only to support main messages in the figures. Meanwhile, a PLS for the next age group (9 to 11) can effectively utilise more text, as long as it is simple with age-appropriate vocabulary.
One trend that the GLSP guidance notes is that for children under 12, a narrative structure is particularly helpful — and that studies associate narratives with increased recall and ease of comprehension. Telling a story that is easily relatable to children helps them identify with what the PLS is trying to convey. For instance, one recommendation is to focus on what the child did in the trial more than on what researchers were doing. In a narrative structure, some amount of accuracy and details may be lost for the sake of storytelling. But sponsors should ensure that the cause-relation of the treatment in question should be clearly described and not compromised.
Still, even with all of these recommendations, the GLSP guidance notes that established standards for child-oriented PLS writing are limited. Few organisations have set practices, and there isn’t yet much scientific research in this area, leaving the GLSP to lean on basic health communication guidelines for children. And while the GLSP guidance provides a starting point for sponsors, there is a dearth of further literature and case studies to establish industry best practices, particularly for the 6 to 11 age range.
ICON’s Insight
In an effort to fill some of the gaps between the regulations for sharing results and the recommendations for creating age-appropriate summaries, ICON, in partnership with CISCRP and Biogen, conducted a small survey of youth from the European Young Persons Advisory Network (eYPAGnet) and KIDS Barcelona. Responses to this survey provided critical insights into how young participants would like to receive information about the results of a trial.
Interestingly, one key takeaway was uncovered: Children overwhelmingly expressed a clear preference for a PLS to be either in a video (100 percent of participants) or a digital (70 percent) format. Of the required elements of a PLS, survey participants felt that the most important were the following:
- Why was the trial conducted?
- What tests were done during the trial?
- How did the treatment work?
- How safe was the treatment?
- What will happen next with the treatment?
Most also expressed an interest in receiving information on how to learn more about the trial. Sponsors may wish to consider an additional paediatric version of the PLS — separate from the end-of-trial PLS required by the European Union Clinical Trial Regulation 536/2014* — tailored to include only the elements that are appealing and understandable to a paediatric audience.
Another consideration is how to disseminate the report. The EU Clinical Trials Information System platform only allows for a single PLS, meaning that summaries for different age groups can’t be provided through the portal. Additionally, younger trial participants may need assistance in understanding the report. To that end, survey participants expressed an interest in learning about trial results from either the doctors who conducted the trial (78 percent), or their primary care physicians (55 percent).
Continuing to Improve
There’s still a long way to go in establishing best practices for a paediatric PLS, which reflect the unique needs of paediatric trial participants. We can continue to improve by engaging children regarding their preferences, and by carefully considering how these audiences may be different from adult clinical trial participants.
To learn more about the survey and the insight and recommendations on paediatric lay summaries, read the article:
Article* European Union Clinical Trial Regulation 536/2014 aims to standardise and harmonise the conduct and management of interventional clinical trials across the European Economic Area, with legally binding rules on requirements and increased transparency.
Resources:
https://ec.europa.eu/health/system/files/2021-10/glsp_en_0.pdf