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The Value of PRO Endpoints in Open Label Oncology Trials
Session Chair(s)
Alan Shields, PhD
Vice President Patient Centered Outcomes
Adelphi Values, United States
The purpose of this session is to consider the FDA’s stated concern regarding the credibility of PRO data collected in studies where subjects are unblinded to study treatment and discuss evidence supporting or refuting the significance of response bias in open label trials.
Speaker(s)
Sponsor Perspective on the Value and Use of PRO Endpoints in Open Label Clinical Trials Oncology Trials
Denise Globe, MHS, PhD
Gilead Sciences, Inc., United States
Executive Director
Methodological Considerations: Considering Respondent Bias in Open Label Trials
David Cella, PhD
Northwestern University, United States
Professor, Department of Medical Social Sciences
An FDA Medical Reviewer's Perspective on PRO Endpoints in Open Label Trials
Virginia Kwitkowski, MS, RN
FDA, United States
Associate Director for Labeling, Division of Hematology Products, OHOP, CDER
Session Summary: What Questions Can Be Answered by PROs in Oncology
Paul Kluetz, MD
FDA, United States
Deputy Director, Oncology Center of Excellence, OC
Q&A Panel Discussion
United States
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