Involving Children, Adolescents, And Parents In Pediatric Drug Development

Involving children in clinical research has long been a sensitive topic associated with several ethical dilemmas and operational challenges. There is now a clear understanding within the medical research community that children can – and do – respond to drugs differently from adults. Thus, new drugs which are intended for use in a pediatric population must be tested in pediatric patients.

Clinical trials in pediatric populations need to be safe for all stakeholders. To that end, it is vital to proactively involve children and parents throughout the clinical trial process, beginning from the early stages of protocol development and extending all the way through study conduct to eventually sharing the outcome of the trial with participating families.

By involving advocacy and support groups like Young Persons’ Advisory Groups and patient organizations, sponsors can develop study-specific recruitment and retention materials in a way that not only reduces the burden on the participating families and encourages study participation, but also connects on a personal level with the child and the family so they are engaged in the trial and committed to do their part to support its success.

In this white paper, we discuss key factors that influence participation in pediatric clinical trials. We also present a case study on a first-of-its-kind survey designed to solicit feedback from children and their families on strategies for encouraging clinical trial participation.