COURSE DESCRIPTION

OVERVIEW

Pediatric clinical research offers unique monitoring challenges when compared to adult clinical trials.  The diversity of developmental cognitive and physiological states throughout childhood, the impact of parents/guardians, and the unique regulatory restrictions placed on vulnerable populations all have consequences regarding how to approach the designing, recruiting, and monitoring of these trials.  Studies that do not take these differences into consideration are potentially doomed to slow study start-ups, unmet timelines, and potential subject injury.  Fortunately, there are ways to ensure your trials secure the right pediatric populations while establishing safety and compliance.

Historical, scientific and regulatory information will be reviewed as part of this presentation along with case scenarios to help build a better understanding of the special considerations encountered with clinical research involving children.  The presentation is divided into five parts:

• A historical review of pertinent pediatric clinical trial legislation
• A discussion regarding the physiological and developmental differences between various pediatric populations as compared to adults
• A discussion of Informed Consent/Permission and Assent in various pediatric populations
• A discussion of IRB review processes in relation to pediatric populations
• A discussion of enrollment issues in pediatric studies and ways to avoid some of these issues

LEARNING OBJECTIVES

By the end of this presentation participants should be able to:

1. Explain the physiological differences between pediatric populations when compared to adults and how they impact on ADME, specimen collection, and dosing
2. Discuss considerations in protocol design when developing a pediatric clinical trial
3. Explain some of the ethical challenges regarding how to consent younger school aged children verses older school aged children and adolescents
4. Discuss enrollment issues and how parent perception can impact on enrollment