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Wednesday, June 29 • 2:00pm - 3:00pm
#351: Emergent Study Designs and Analysis Methods Addressing Issues Associated with Pediatric Clinical Studies

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-585-L01-P; CME 1.00; IACET 1.00; RN 1.00

Traditional clinical study designs and analysis methods may not be applicable to some pediatric studies due to unique issues with the pediatric population. This session presents emergent designs and methods appropriate to addressing these issues.

Learning Objectives

Recognize how clinical study design and statistical analysis methods can ease difficulties often found in pediatric clinical trials; Assess study designs and statistical methodology not typically used in standard clinical trials appropriate for pediatric clinical trials; Identify when and who to consult to improve the efficiency within a pediatric clinical trial.

Chair

Tammy J. Massie

Speaker

Enhancing Pediatric Clinical Trial Feasibility: Focus on the Use of Bayesian Statistics
Earl Seltzer, MBA

Panelist
Lisa A Kammerman, PhD, MS



Chair
avatar for Tammy Massie

Tammy Massie

Mathematical Statistician, Office of Equal Opportunity and Customer Outreach, National Institutes of Health (NIH)
Tammy Massie has worked as a mathematical statistician at various centers in the FDA for the past 13 years. In spring 2016, Tammy moved to NIH to perform statistical work on a variety of demographic subgroups within the Office of Equity, Diversity and Inclusion. Tammy recieved her... Read More →

Speakers
LK

Lisa Kammerman

Senior Statistical Science Director, AstraZeneca
Lisa Kammerman, PhD is a Senior Statistical Director in Oncology at AstraZeneca. She consults on PRO projects and regulatory submissions. She developed AZ's PRO guidance document and led AZ's missing data project. After 24 years of public service, she retired from the FDA, where she... Read More →
avatar for Tammy Massie

Tammy Massie

Mathematical Statistician, Office of Equal Opportunity and Customer Outreach, National Institutes of Health (NIH)
Tammy Massie has worked as a mathematical statistician at various centers in the FDA for the past 13 years. In spring 2016, Tammy moved to NIH to perform statistical work on a variety of demographic subgroups within the Office of Equity, Diversity and Inclusion. Tammy recieved her... Read More →
avatar for Earl Seltzer

Earl Seltzer

Associate Therapeutic Strategy Director, Therapeutic Science and Strategy, Quintiles
I have 10 years of industry experience, starting as a clinical research coordinator and moving to site management and business development oversight for a large mutlispecialty research site in Raleigh, NC that focused on adult and pediatric phase Ib-IV clinical trials. For the past... Read More →
avatar for Earl Seltzer

Earl Seltzer

Associate Therapeutic Strategy Director, Therapeutic Science and Strategy, Quintiles
I have 10 years of industry experience, starting as a clinical research coordinator and moving to site management and business development oversight for a large mutlispecialty research site in Raleigh, NC that focused on adult and pediatric phase Ib-IV clinical trials. For the past... Read More →


Wednesday June 29, 2016 2:00pm - 3:00pm
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA