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Session 5: The Use of Patient Experience Data to Inform Benefit- From Instrument to Label Claim
Session Chair(s)
Jonathan Haddad, MPH
HIV Disease Area Head, Clinical Statistics
GlaxoSmithKline, United States
Scott Komo, DrPH
Lead Mathematical Statistician, Office of Translational Sciences, CDER
FDA, United States
This session will cover the development and use of patient experience data under the framework established by the 21st Century Cures Act. Through the use of examples, speakers will examine the steps and requirements to establish usable patient experience endpoints and examine how these data are analyzed and used to inform the benefit-risk assessment in the US drug approval and labeling process.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Understand the role of the 21st Century Cures Act in enabling the inclusion of patient experience endpoints in drug development
- Gain awareness of the process for identifying and developing measures of patient experience
- Understand the role of COA office in regulatory acceptance of patient experience endpoints
- Gain insight of how these data are evaluated in the FDA review process
Speaker(s)
Incorporating Patient Preferences into Regulatory Decision-Making
Telba Irony, PhD, MS, MSc
Janssen R&D, United States
Senior Scientific Director, Quantitative Sciences
Characterizing Patient Experience Endpoints with Patient Reported Outcomes
Josephine Park, MBA, MPH
GlaxoSmithKline, United States
Director, Patient Reported Outcomes
Panelist
Laura Lee Johnson, PhD
FDA, United States
Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER
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