Skip to main content

Applying the FDA Patient-reported Outcome (PRO) Guidance…

1 Presentation 0 Sections

Applying the FDA Patient-reported Outcome (PRO) Guidance to Performance Outcome (PerfO) Measures

Organized By: Industry SIG (Formerly the Industry Advisory Committee – IAC)

The FDA PRO Guidance of 2009 provides a gold standard against which the appropriateness of PRO measures for use in clinical trials are assessed. The principles that apply to PROs broadly apply to other types of assessments such as PerfOs.

This webinar provides examples of PerfOs, including cognitive and physical functioning assessments and highlights the importance of establishing conceptual relevance and ecological validity. Included is an overview of innovative technologies such as preference-based studies, cognitive task analysis and video diaries.

Learning Outcomes/Objectives
After the webinar, the learner will be able to:
  • Understand the importance of conceptual relevance and ecological validity of PerfOs
  • Learn how innovative methods (e.g. cognitive task analysis) provide insights into decision making when administering and completing these tasks

  • Fiona McDougall, PhD ClinPsyD, Roche Products Limited
  • Louise Humphrey, MSc
  • Lee Scott Ehrhart, PhD, MITRE Corporation
  • Helen A. Doll, MSc DPhil, ICON Patient Reported Outcomes

  • Moderator
  • Diana Rofail, CPsychol, Roche Products Limited

  • Sponsor:

    Recording Policy
    Photography, video or audio recording (including screen capture) of ISOQOL courses, sessions, digital materials, or ISOQOL graphics without written permission from ISOQOL is strictly prohibited.

    Note that photographs and video recordings taken by or on behalf of ISOQOL is the property of ISOQOL.

    ISOQOL members receive a discounted rate. To view membership rates, click  here.