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Patient-Reported Outcomes (PROs): Hot Topics - Part 2 of 2
Session Chair(s)
Dennis Revicki, PHD
Senior Vice President, and Executive Director, COE for Outcomes Research
Evidera, 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)
Developing and Evaluating PRO Instruments in Clinical Trials: Risks and Advantages for Applications Using Registration Trials
Dennis Revicki, PHD
Evidera, United States
Senior Vice President, and Executive Director, COE for Outcomes Research
Developing and Evaluating PRO Instruments in Clinical Trials: Overview and Importance of Key Psychometric Characteristics
Wen-Hung Chen, PHD
FDA, United States
Social Science Analyst, Office of New Drugs, CDER
Developing and Evaluating PRO Instruments in Clinical Trials: Statistical Issues for Applications Using Registration Trials
Lisa A Kammerman, PHD, MS
Kammerman Consulting, LLC, United States
Regulatory Statistics and PRO Consultant
Panelist
Laura Lee Johnson, PHD
FDA, United States
Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER