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Meeting Registration: 

Twitter: #OCEOutcomes24

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) 9th annual workshop.

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

Assessing tolerability from the patient perspective is necessary in cancer trials. Given the availability of PRO symptom item libraries and the growing list of oncology therapeutic mechanisms of action, parsimonious selection of relevant side effects is critical. This year, we will discuss methodologies to select patient-reported treatment-related symptoms to rigorously assess within cancer clinical trials. 

Meeting Goals

1. Provide contextual background for patient-reported symptom assessment – an overview of existing “core” symptom sets.
2. Review how current clinical trials require novel methods to select symptoms, including use of PRO item libraries.
3. Emphasize how early phase trials, pediatric trials, and use of novel agents require parsimonious symptom assessment.
4. Consider actionable methods to modernize existing PRO item libraries.
5. Discuss a framework for selecting treatment related symptoms across many therapeutic contexts. 
6. Review analysis and visualization techniques for treatment related symptoms assessed during cancer trials.

Workshop Materials

• Agenda
• Biographies

For past COA-CCT workshops, go to the events section 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
Tel: 301.318.8609
Caitlin.Drew@fda.hhs.gov

Joan Ferlo Todd, 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
Joan.Todd@fda.hhs.gov

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