Full course description
A general overview of pediatric trials, discussing pediatric subpopulations, laws related to pediatric research, the consent process, and clinical trial design considerations. The level of cognitive ability of developing children, ethics, the physiological changes associated with human growth, and data biases associated with age will be highlighted. A case study investigating the effects of caffeine on newborns and whether breast feeding versus formula feeding affected caffeine metabolism differently is presented.
1. Identify the laws promoting pediatric participation in clinical research.
2. Distinguish between the diverse sub-populations that comprise the pediatric population.
a. Define terms related to pediatric participation in research (i.e., parental permission, assent, and consent)
b. Identify two complexities unique to pediatric clinical research and recruitment bias.
1. Pediatric trials are hard, so why do them?
2. Who are “Children”?
3. Assent vs. Consent
4. How do logistics and recruitment bias data?
a. Children five years of age and older are legally required to attend school
b. Parent/guardian’s stigma and biases about allowing their child to participate in research
c. Eliciting children’s participation especially for research involving interviews, questionnaires, surveys, and other tools with both qualitative and quantitative elements
5. Example: Studying caffeine in newborns
6. Are my outcomes measurable in this child?