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Activity Number: 559
Type: Contributed
Date/Time: Wednesday, August 3, 2016 : 10:30 AM to 11:15 AM
Sponsor: Biopharmaceutical Section
Abstract #321601
Title: Explore Methodologies for Extrapolation of Efficacy from the Adult to the Specific Pediatric Population
Author(s): Yao Li* and Bidan Huang
Companies: AbbVie and AbbVie
Keywords: Clinical Trial ; Pediatric ; Extrapolation

Ethical considerations are always paramount in pediatric trials because of the risk of disease complications in children who carry a higher disease burden than adults. In addition, enrolling children in a pediatric trial with a placebo arm is challenging. When applicable, extrapolating efficacy from adult data to children can reduce the number and complexity of pediatric trials in the drug development. On top of that, the measurement for disease severity and disease improvement used in pediatric population may also be different from the one used in adults. The important challenge in extrapolation is to quantify the similarity of both disease and clinical response between adults and children. To explore the methodologies of extrapolation between the adult and pediatric efficacy, we simulate Pediatric Crohn's Disease Activity Index (endpoint for children) and Crohn's Disease Activity Index (endpoint for adults and children age 13 to 17) that mimic a clinical trial setting. This will allow us to calculate the remission rates and further explore the relationship of these two endpoints between the children and adults.

Authors who are presenting talks have a * after their name.

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