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Monday, June 26 • 1:30pm - 2:30pm
Patient-Reported Outcome Measures to Support Oncology Clinical Development and Labeling: Responding to FDA’s Draft Guidance

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Component Type: Session
Level: Intermediate

In June '21, FDA issued draft guidance on core PROs in cancer trials. This provides insight into regulatory thinking, and may lead to more future PRO-based labeling. This session explores how the guidance might affect study design and PRO development.

Learning Objectives

Describe the limitations in current measurement strategy for patient-reported outomces in oncology trials; Discuss specificity of measures and its importance in PRO selection; Review how item banks can be used to ensure good measure selection and development.

Chair

Bill Byrom, PhD

Speakers
avatar for Bill Byrom

Bill Byrom

Vice President, Product Intelligence and Positioning; Principal, eCOA Science, Signant Health , United Kingdom
Bill is an eCOA scientist and VP of product intelligence and positioning at Signant Health. He has worked in the Pharmaceutical industry for over 30 years and is the author of over 70 publications and two industry textbooks on ePRO. His recent scientific work includes the use of wearable... Read More →

Monday June 26, 2023 1:30pm - 2:30pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Session