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Wednesday, June 22 • 12:45pm - 1:15pm
#336 CH: Reviewing FDA's Draft Guidance on PROs in Oncology Trials: How This Affects Future Measurement Strategy and Study Designs

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Component Type: Workshop
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In June '21, FDA issued draft guidance on core PROs in cancer trials.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 selection.

Learning Objectives

Identify if existing gold standard measures are fit for purpose; Explore the impact of the guidance on PRO selection and adaptation; Discuss how to optimize study designs to meet the requirements of the guidance, and what this means practically for patients and sites.


Bill Byrom, PhD

Wednesday June 22, 2022 12:45pm - 1:15pm CDT
Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616