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  4. FDA WORKSHOP: 10th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop OCTOBER 8, 2025 - 10/08/2025
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Virtual | Virtual

Event Title
FDA WORKSHOP: 10th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop OCTOBER 8, 2025
October 8, 2025

Reflecting on a Decade of Progress

Date:
October 8, 2025
Time:
1:00 p.m. - 3:30 p.m. ET
Organized By:
Organizer

Presented by the Oncology Center of Excellence

Background

The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) Patient-Focused Drug Development (PFDD)  program welcomes you to the Clinical Outcome Assessment in Cancer Clinical Trials (COA-CCT) 10th annual workshop.

Each year, the COA-CCT workshop provides a forum for collaborative and productive multidisciplinary discussions to advance the understanding of the regulatory and scientific issues surrounding the use of patient-reported outcome (PRO) measures in cancer clinical trials.

This workshop will review the FDA guidance on core PROs, finalized in 2024, and discuss how these core outcomes have been used to describe patient experience using recent examples from oncology product labeling.

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.

Workshop Materials

For past COA-CCT workshops, go to the events section of the FDA OCE Patient-Focused Drug Development Program webpage.

Contacts 

Caitlin Drew, MSN, RN
Senior Health Scientist 
Oncology Center of Excellence, (OCE)
Office of the Commissioner (OC)
U.S. Food and Drug Administration
10903 New Hampshire Ave, Silver Spring, MD 20993
Caitlin.Drew@fda.hhs.gov

Event Materials

Title File Type/Size
final_agenda_oct_2025_coa_cct_508_lro.pdf pdf (171.85 KB)
participant_biographies_oct_2025_coa_cct_508_lro.pdf pdf (440.96 KB)
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