Presentation
MDD17 - How Young is Too Young? Study Design Challenges in the Inclusion of Youth as a Cohort for Self-Administration
SessionPoster Session 2
DescriptionDrug device combination products are being developed for intended user groups that include children (2-11 years of age) and/or adolescents (12-21 years of age) as some of the intended user groups. Increasingly, the agency has provided feedback asking for children as young as age 10 to be included as a unique self-administration cohort for the combination product if youth are part of the intended user population. This presentation discusses study design considerations and challenges with the inclusion of children younger in age in human factors usability studies of drug device combination products.
Topics to be discussed include the ability of children to interact with and use all the components of the complete device user interface, from the device itself to the labeling, packaging, instructions, and any other components. The ability of a 10-year-old to read and comprehend product labeling is of particular concern as the FDA guidance on patient labeling indicates that instructions and other labeling should be written to no higher than an 8th grade reading level, while a 10-year-old is often in 4th or 5th grade. Additionally, physical limitations in a child’s ability to handle the product(s) will be discussed as well as the impacts on the design verification for the expanded user population from children to adults.
Inclusion of a child and/or adolescent population as an additional study cohort(s) adds challenges to the study design and demands on the planning resources, including recruiting costs and scheduling, timeline, and root cause investigation. Finally, study design options for inclusion of children as an exploratory subgroup, different options for parental involvement, and final considerations on the acceptability of children as viable candidates for self-injection will be discussed.
Topics to be discussed include the ability of children to interact with and use all the components of the complete device user interface, from the device itself to the labeling, packaging, instructions, and any other components. The ability of a 10-year-old to read and comprehend product labeling is of particular concern as the FDA guidance on patient labeling indicates that instructions and other labeling should be written to no higher than an 8th grade reading level, while a 10-year-old is often in 4th or 5th grade. Additionally, physical limitations in a child’s ability to handle the product(s) will be discussed as well as the impacts on the design verification for the expanded user population from children to adults.
Inclusion of a child and/or adolescent population as an additional study cohort(s) adds challenges to the study design and demands on the planning resources, including recruiting costs and scheduling, timeline, and root cause investigation. Finally, study design options for inclusion of children as an exploratory subgroup, different options for parental involvement, and final considerations on the acceptability of children as viable candidates for self-injection will be discussed.
Event Type
Poster Presentation
TimeTuesday, April 14:45pm - 6:15pm EDT
LocationFrontenac Foyer