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Pediatric Trials: Improvements through Bayesian Methods, Adaptive Designs, and Modeling/Simulation

Track:
Statistical Science and Quantitative Thinking

Day & Time:
June 18, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
398

Room Number:
11B

Level:
Advanced

Type:
Session

Title:
Pediatric Trials: Improvements through Bayesian Methods, Adaptive Designs, and Modeling/Simulation

Chair(s):
Gesine Bejeuhr, PharmD
Senior Manager, Regulatory Affairs/Quality
vfa Research-based Pharmaceutical Companies, Germany

Description:
This session provides practical examples of how Bayesian methods, adaptive designs and other statistical methods including modeling and simulation could contribute to pediatric trials and lead to better design and fewer children to be exposed. This session will stimulate a dialogue between technical experts in statistics/adaptive design and those who are involved in clinical trials, particularly examining pertinent questions: (1) What are the messages from statistics/adaptive design to be understood by those who are involved in pediatric development and then by those who are asked to consent to participate in clinical trials?, (2) What are the messages for key decision makers in pharmaceutical companies to agree to adaptive design/Bayesian or any other method?, and (3) What do authorities need?

This session has been developed by the DIA Pediatric Community and the Bayesian and Adaptive Design Scientific Working Groups.

Learning Objective(s):
Describe results of the collaboration between the DIA Pediatric Community and Bayesian and Adaptive Design Scientific Working Groups; Examine potential applications of Bayesian methods and adaptive designs to improve pediatric medical product development; Identify opportunities to collaborate on application of novel approaches in pediatric designs via open discussion and case examples; Provide information to prepare the right messages to patients, investigators, and industry decision-makers.

Presentation(s) & Speaker(s):
Bayesian Statistics and Adaptive Design
Scott M Berry, PhD
President and Senior Statistical Scientist
Berry Consultants LLC, United States

Pediatric Studies and Bayesian Statistics: Challenges and Opportunities
Freda W. Cooner, PhD
Lead Mathematical Statistician, Div. of Biometrics III, OB, OTS, CDER
FDA, United States

Pharmaceutical Company Perspective
Brenda Cirincione
Director, Clinical Pharmacology and Pharmacometrics
Bristol-Myers Squibb Company, United States