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Activity Number: 605 - Innovations in Use of Historical Control Data in Clinical Trials
Type: Topic Contributed
Date/Time: Thursday, August 1, 2019 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #306719 Presentation
Title: Incorporation of Historical Information in Pediatric Trials
Author(s): James Travis*
Companies: FDA
Keywords: Bayesian; Pediatric; Borrowing; Historical

Due to various issues it can be difficult and time-consuming to sufficient enroll pediatric clinical trials. In 2005, Goodman and Sladky [1] proposed using Bayesian methodologies to incorporate information from other trials (adults or older pediatrics) in the same indication to pediatric trials to reduce the quantity of information that needs to be directly collected. I will present an example of a Bayesian approach which uses a robust mixture prior approach which uses a weighted combination of the available information combined with an uninformative prior to allow a flexible discounting of the external information. I will also discuss regulatory issues with these approaches.

1 – Goodman, Steven N., and John T. Sladky. "A Bayesian approach to randomized controlled trials in children utilizing information from adults: the case of Guillain-Barre." Clinical Trials 2.4 (2005): 305-310.

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