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Activity Number: 304 - Extrapolation as a Default Strategy in Pediatric Drug Development: Implications to Clinical Trial Designs and Statistical Analysis
Type: Topic Contributed
Date/Time: Wednesday, August 5, 2020 : 10:00 AM to 11:50 AM
Sponsor: Biopharmaceutical Section
Abstract #313748
Title: Bayesian Analysis in Pediatric Settings
Author(s): Mark Rothmann*
Companies: Division of Biometrics II, Office of Biostatistics, OTS, CDER, FDA
Keywords: Pediatric Clinical Trials; Bayesian Analysis; Leveraging Data

Typically, the effects of medical products are studied in children after marketing approval in adults. Despite success in adult studies, clinical trials in children may fail to demonstrate efficacy. This may be due to differences between adults and children in physiology, disease pathology, exposure to the product, or tolerability of the product. This could also be due to an undersized pediatric study. Undersized studies can produce inconclusive results with little incentive to further study the medical product in children. The question of whether a drug works in children is not same as whether it works in adults, but it’s not completely separate, either. Decisions on the effectiveness and safety of medical products in children can consider relevant adult data through Bayesian approaches. I will discuss innovative approaches to pediatric drug development.

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

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