PROMIS in the Regulatory Landscape
- Presenter(s): David Cella; Robyn Bent; Sonya Eremenco; John Devin Peipert
- Session Length: 75 minutes
- Date: Oct 26, 2025
This session will provide an in-depth analysis and discussion of current practices around use of PROMIS-based evidence for treatment approval and labeling claims among regulators. There will be a specific focus on the US FDA's patient-focused drug development program and guidance, and approaches for implementing PROMIS in this context.
Moderator: David Cella, PhD, Northwestern University
Overview of Patient Focused Drug Development - Presenter: Robyn Bent, RN, MS, U.S. Food and Drug Administration
The PROMIS Journey to Qualification: Critical Path Institute's Experience with FDA's COA Qualification Program - Presenter: Sonya Eremenco, MA, Critical Path Institute (C-Path)
Key Methodological Issues in Patient Focused Drug Development: Considerations for PROMIS Users - Presenter: J. Devin Peipert, PhD, University of Birmingham
Description: This session will provide an in-depth analysis and discussion of current practices around use of PROMIS-based evidence for treatment approval and labeling claims among regulators. There will be a specific focus on the US FDA's patient-focused drug development program and guidance, and approaches for implementing PROMIS in this context.
Moderator: David Cella, PhD, Northwestern University
Overview of Patient Focused Drug Development - Presenter: Robyn Bent, RN, MS, U.S. Food and Drug Administration
The PROMIS Journey to Qualification: Critical Path Institute's Experience with FDA's COA Qualification Program - Presenter: Sonya Eremenco, MA, Critical Path Institute (C-Path)
Key Methodological Issues in Patient Focused Drug Development: Considerations for PROMIS Users - Presenter: J. Devin Peipert, PhD, University of Birmingham
Description: This session will provide an in-depth analysis and discussion of current practices around use of PROMIS-based evidence for treatment approval and labeling claims among regulators. There will be a specific focus on the US FDA's patient-focused drug development program and guidance, and approaches for implementing PROMIS in this context.
description
This session will provide an in-depth analysis and discussion of current practices around use of PROMIS-based evidence for treatment approval and labeling claims among regulators. There will be a specific focus on the US FDA's patient-focused drug development program and guidance, and approaches for implementing PROMIS in this context.Moderator: David Cella, PhD, Northwestern University
Overview of Patient Focused Drug Development - Presenter: Robyn Bent, RN, MS, U.S. Food and Drug Administration
The PROMIS Journey to Qualification: Critical Path Institute's Experience with FDA's COA Qualification Program - Presenter: Sonya Eremenco, MA, Critical Path Institute (C-Path)
Key Methodological Issues in Patient Focused Drug Development: Considerations for PROMIS Users - Presenter: J. Devin Peipert, PhD, University of Birmingham
Description: This session will provide an in-depth analysis and discussion of current practices around use of PROMIS-based evidence for treatment approval and labeling claims among regulators. There will be a specific focus on the US FDA's patient-focused drug development program and guidance, and approaches for implementing PROMIS in this context.
