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Monday, June 27 • 8:30am - 9:45am
#118: The Interpretation of PRO Scores and Responder Analyses in the Presence of Missing Data

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Limited Capacity seats available
Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will review best practices for quantifying a meaningful change in a patient-reported outcome (PRO) endpoint and establishing a responder definition in the presence of missing score data. Missing data strategies that do not assume absence of a PRO score means “non-responder.”

Learning Objectives

Recognize problems in responder analyses if subjects discontinue study treatment or withdraw from a trial; Compare approaches published by EMA, NAS, and in the ICH E9(R1): Addendum to Statistical Principles for Clinical Trials on Choosing Appropriate Estimands and Defining Sensitivity Analyses in Clinical Trials; Recognize how to combine multiple missing data approaches to tell the data story.

Chair

Scott Komo, DrPH

Speaker

Panelist
Yeh-Fong Chen, PhD

Panelist
Lisa A Kammerman, PhD, MS


Chair
SK

Scott Komo

Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Scott Komo is a Senior Statistical Reviewer in the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. He is involved with the design, analysis, and interpretation of studies that use clinical outcome assessments. He has supported multiple medical areas since joining... Read More →

Speakers
avatar for Yeh-Fong Chen

Yeh-Fong Chen

Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Dr. Yeh-Fong Chen is the statistical team leader supporting the Division of Gastroenterology and Inborn Errors Products at the Division of Biometrics III at US Food and Drug Association. She joined FDA in 2000 immediately after graduation with a PhD degree in Statistics from the University... Read More →
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 →
SK

Scott Komo

Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Scott Komo is a Senior Statistical Reviewer in the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. He is involved with the design, analysis, and interpretation of studies that use clinical outcome assessments. He has supported multiple medical areas since joining... Read More →

Monday June 27, 2016 8:30am - 9:45am
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 15: Statistics, Forum