Tuesday, June 20 • 4:00pm - 5:15pm
#287: Patient-Reported Outcomes (PROs): Hot Topics - Part 2 of 2

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-558-L04-P; CME 1.25; IACET 1.25; RN 1.25

Patient-reported outcomes (PROs)are not new. The FDA released a final guidance on this topic in 2009, and there have been many presentations and discussions on the evidence and measurement principles used to guide development of fit-for-purpose PRO assessments. This session will move the conversation from basic PRO development to discuss the latest hot topics regarding PROs in drug development. Hot topics might include (but are not limited to): FDA's flexibility in implementing principles in the guidance; methods to evaluate meaningful change on PRO assessments; strategies for incorporating PRO endpoints into multiplicity-adjusted endpoint hierarchy with traditional endpoints; novel methods to validate new PRO tools).

Learning Objectives

Summarize practical insights and methods that can be used to facilitate the development and use of PROs in clinical trials.


Dennis Revicki, PhD


Developing and Evaluating PRO Instruments in Clinical Trials: Risks and Advantages for Applications Using Registration Trials
Dennis Revicki, PhD

Developing and Evaluating PRO Instruments in Clinical Trials: Overview and Importance of Key Psychometric Characteristics
Wen-Hung Chen, PhD

Developing and Evaluating PRO Instruments in Clinical Trials: Statistical Issues for Applications Using Registration Trials
Lisa A. Kammerman, PhD, MS

Laura Lee Johnson, PhD


Dennis Revicki

Senior Vice President, and Executive Director, COE for Outcomes Research, Evidera
Dennis Revicki, PhD is a Senior Vice President, Outcomes Research, Evidera, Bethesda, MD, USA. He has over 30 years experience in patient-reported outcome development and psychometric evaluation, clinical trial methods and analysis, developing patient-reported outcome assessment strategies... Read More →


Wen-Hung Chen

Social Science Analyst, Office of New Drugs, CDER, FDA
Wen-Hung Chen is a reviewer in the Clinical Outcome Assessment Staff in the Office of New Drugs, Center for Drug Evaluation and Research, FDA. Dr. Chen’s responsibility includes supporting the review divisions in issues related to the development and interpretation of study endpoints... Read More →

Laura Lee Johnson

Director Division III, Office of Biostatistics, OTS, CDER, FDA
Laura Lee Johnson, Ph.D. is a division director in the Office of Biostatistics at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). She specializes in design, logistics, and analysis of research from clinical outcome assessment (COA) qualification... Read More →

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 →

Tuesday June 20, 2017 4:00pm - 5:15pm
S404d McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616