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Monday, June 25 • 3:00pm - 4:15pm
#154: Bayesian Application in Small-Sized Clinical Trials

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Component Type: Session
Level: Advanced
CE: ACPE 1.25 Application UAN: 0286-0000-18-551-L04-P; CME 1.25; IACET 1.25; RN 1.25

The use of historical data demonstrates value and efficiency in designing clinical trials, especially in nonconfirmatory trials. This session presents an overview of theoretical framework, case studies in exploratory situations, and future directions.

Learning Objectives

Describe the use of historical information on controls in rare disease and pediatric settings; Discuss the challenges and concerns in design of confirmatory trials; Analyze industry and regulatory point of view and potentially pilot solutions.


Fei Wang, PhD


Incorporating Adult Study Data into Pediatric Clinical Trials: Is Bayesian Borrowing the Solution?
James Travis, PhD

Approaches to Medical Device Evaluation Using Real-World Evidence
Sharon-Lise Normand

Bayesian Applications for Extrapolation from Adult to Pediatric Data
Amy Xia, PhD


Sharon-Lise Normand

Professor of Health Care Policy (Biostatistics), Harvard Medical School
Sharon-Lise Normand, Professor of Health Care Policy, Department of Health Care Policy at Harvard Medical School & Professor, Department of Biostatistics, Harvard School of Public Health focuses on the development of statistical methods for health services & outcomes research, including... Read More →
avatar for James Travis

James Travis

Senior Staff Fellow, OB, OTS, CDER, FDA, United States
James Travis is a statistical reviewer in the Division of Biometrics II in the Office of Biostatistics in CDER. James joined the Agency in 2014 following completion of his PhD at the University of Maryland, Baltimore County. He is a member of the pediatric and maternal health statistical... Read More →

Fei Wang

Senior Manager, Biostatistics, Amgen
As a statistician, Dr. Wang has worked in both academia and pharmaceutical industry. Her research focuses on statistical methods for Bayesian design and hierarchical modeling, including applications for clinical trials in drug development, medical device evaluation, and health outcomes... Read More →
avatar for Amy Xia

Amy Xia

Vice President, Biostatistics, Design & Innovation, Amgen Inc.
Amy Xia is Vice President, Biostatistics, Design & Innovation at Amgen. Amy has worked on designing, implementing, and analyzing Phase I-IV clinical trials as well as observational studies in the past 22+ years. Currently, she heads up the Biostatistics and Design & Innovation organizations... Read More →

Monday June 25, 2018 3:00pm - 4:15pm EDT
Room 256 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  11: Statistics, Session