Understanding FDA Guidance on Patient-Reported Outcomes in Oncology Trials

Signant’s eCOA and oncology experts discuss the key takeaways from the FDA’s draft guidelines on patient-reported outcomes in oncology trials and its implications for trial design.

The discussion covers four key aspects of the FDA guidance and provides recommendations about:

• Current patient-reported outcome measures (PROMs) labelling & oncology challenges
• How to address PROM specificitiy: core measurement domains
• Ideal measurement timing & frequency
• Changes needed for eCOA design and implementation

Watch the webinar to ensure you’re properly prepared to meet FDA expectations in your cancer trials.