FDA WORKSHOP: 10th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop

The FDA Oncology Center of Excellence’s Patient-Focused Drug Development (PFDD) program will host the 10th Annual Clinical Outcome Assessment in Cancer Clinical Trials (COA-CCT) Workshop, focusing on the use of patient-reported outcome (PRO) measures in oncology trials. This year’s workshop will highlight the finalized 2024 FDA guidance on core PROs and showcase recent examples of how these outcomes are used in oncology product labeling to reflect patient experience.

Meeting Goals

1. Examine the integration of patient-generated data into regulatory submissions over the past decade.
2. Discuss research that has advanced the science of analyzing PROs.
3. Analyze historical examples of how core PRO data have been incorporated into labeling for anti-cancer products.
4. Review how PRO core outcomes have been utilized in cancer drug development.
5. Explore future directions for the analysis and visualization of PRO data.
6. Identify key, achievable milestones for advancing PRO data science and its regulatory use over the next five years.

Visit the event page for more information.