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Activity Number: 571 - Special Topics and Case Studies in Clinical Trials
Type: Contributed
Date/Time: Wednesday, July 31, 2019 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #306797
Title: Dealing with Issues of Pediatric Clinical Trials
Author(s): Aobo Wang*
Companies: Merck
Keywords: Pediatric; Stopping Rule; Sample Size; Safety
Abstract:

Conducting pediatric clinical trials always involves stricter requirements from the regulatory agency than adult clinical trials, regarding the sample sizes and safety concerns. This presentation will focus on how to deal with some common issues for pediatric studies, including: 1) Adjusting randomization ratios to meet the minimum requirement of sample size from safety perspective; 2) Developing stopping rules related to specific Adverse Event or Event of Clinical Interest.


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

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