EP.48Informing paediatric clinical research participants: an innovative approach

Abstract

Engaging children in clinical trials is a priority in paediatric research, however how an informed assent for taking part in research can be obtained in young children is topic of debate. Clinical trial designs often include invasive procedures, extensive and frequent trial visits, potentially impacting the daily life of families. Deciding whether to participate in a clinical trial or between trials can be daunting for parents and children. In any paediatric research, it is vital that engaging and clear information is provided to the children so they can make fully informed decisions. In 2015, we developed a screen-based animation, narrated by a child, to explain a Duchenne muscular dystrophy (DMD) exon-skipping trial to young children. Feedback from trial participants was positive. A further electronic application using a mix of video and animations was developed to explain the use of an activity band as part of the Horizon 2020 funded Vision DMD project (drug development programme for vamorolone in DMD). Based on these pilot projects, a digital App has been developed for the Phase 2b Vision DMD study. The App, uses animation to show participants what clinical research is, what participation in the clinical trial involves and explains study assessment and procedures. The App will be used in selected countries as part of the assent process; parents will be advised to show the App to the child at home prior to first visit, and the site Investigator will present the study to the child through the App as part of screening procedures. Questionnaires to collect parent feedback on the assent process and evaluate the understanding of the trial by the child have been developed. This will compare the traditional assent process, using paper patient information leaflet, and use of the App. If this innovate approach to informing children proves to be meaningfully beneficial, it may have significant impact on how we communicate with children about clinical trials in future.