DIA 2022 Global Annual Meeting

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In June '21, FDA issued draft guidance on core PROs in cancer trials.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