Pediatric Clinical Trials: Special Considerations and Requirements
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 four 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
By the end of this presentation participants should be able to:
- Explain the physiological differences between pediatric populations when compared to adults and how they impact on ADME, specimen collection, and dosing
- Discuss considerations in protocol design when developing a pediatric clinical trial
- Explain some of the ethical challenges regarding how to consent younger school aged children verses older school aged children and adolescents
- Discuss enrollment issues and how parent perception can impact on enrollment
This course will be of benefit to anyone involved in designing, conducting, recruiting, or monitoring pediatric clinical trials with a particular emphasis on pharmaceuticals.
Charles “Chuck” Sather, CCRA has been a clinical research consultant for approximately 13 years specializing in the risk-based monitoring of pediatric and adult pharmaceutical, biologic and medical device clinical trials, in compliance and data management auditing and in training and education. In 2002 he co-founded Clinical Pathways (CP), LLC with Sandra “SAM” Sather. More than 1/3 of his experience in clinical research has been as a monitor/consultant on a variety of pediatric and neonatal clinical trials. He graduated Summa Cum Laude from UCLA with a BSN and has an additional 15 years of experience predominantly in pediatric and neonatal nursing.
His current focus is to promote efficiency in monitoring and auditing in a balanced, fair and amiable manner. He is a frequent speaker at industry conferences, has authored/co-authored multiple courses for clinical research training programs in various functional areas and has participated as an Item Writer on ACRP’s Exam Committee.