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Patient-Reported Outcomes (PROs): Hot Topics - Part 1 of 2
Session Chair(s)
Selena Daniels, PharmD, PhD, MS
Team Leader, Division of Clinical Outcome Assessment, ODES, CDER
FDA, United States
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 Objective : Summarize practical insights and methods that can be used to facilitate the development and use of PROs in clinical trials.
Speaker(s)
Capturing the Patient's Voice in Evaluating Safety and Tolerability: Industry Perspective
Arnold Degboe, MD, PhD, MBA
AstraZeneca, United States
Director, Patient Science-Oncology, Patient Centricity, Global Medical Affairs
Capturing the Patients’ Voice in the Evaluation of Safety and Tolerability: FDA Perspective
Paul Kluetz, MD
FDA, United States
Deputy Director, Oncology Center of Excellence, OC
Capturing the Patients’ Voice in the Evaluation of Safety and Tolerability: FDA Perspective
Ann Marie Trentacosti, MD
FDA , United States
Medical Officer, Labeling Development Team, OND, CDER
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