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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#336 CH: Reviewing FDA's Draft Guidance on PROs in Oncology Trials: How This Affects Future Measurement Strategy and Study Designs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In June '21, FDA issued draft guidance on core PROs in cancer trials.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.

Chair

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