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PRO Endpoints as Primary or Co-Primary Endpoints in Oncology Trials
Session Chair(s)
Alan Shields, PhD
Vice President Patient Centered Outcomes
Adelphi Values, United States
The purpose of this session is to provide the audience with evidence supporting the position that patient-centered outcomes can and should be considered legitimate and credible contributors to treatment efficacy claims in regulated clinical trials.
Speaker(s)
Introduction
Alan Shields, PhD
Adelphi Values, United States
Vice President Patient Centered Outcomes
When and Why Should PRO Endpoints be Primary in Oncology Trials?
John H. Powers, MD, FACP
George Washington University School of Medicine, United States
Professor of Clinical Medicine
Evidence Supporting Symptom Burden as a Co-Primary Endpoint Along with Survival
Alicyn Campbell
Genentech, A Member of the Roche Group, United States
Global Head of Patient-Centered Outcomes Research for Oncology Prod. Dev.
An FDA COA Staff Perspective
Ashley F. Slagle, PhD, MS
Aspen Consulting, LLC, United States
Principal, Scientific and Regulatory Consulting
Q&A Panel Discussion
United States
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