2025 Clinical Outcome Assessment Program Annual Meeting

Save the Date!
2025 Clinical Outcome Assessment Program Annual Meeting

On April 9-10, 2025, the 2025 Clinical Outcome Assessment Program Annual Meeting will be held at the Bethesda North Marriott & Conference Center, Rockville, MD.  Topics to be covered during this year’s event include:

  • Update on FDA’s Clinical Outcome Assessment (COA) Qualification Program and other FDA initiatives
  • The potential of AI for COA development and deployment in clinical trials
  • Regulatory pathways for using patient experience data pre- and post-approval: navigating benefit-risk assessment and communications consistent with labeling
  • Unique considerations for collection of clinical trial endpoints in rare diseases
  • Generating patient-centered evidence that addresses regulatory, access, patient, and other stakeholder expectations: navigating a varied landscape
  • Current thinking on the accessibility and burden of eCOA & DHT system use
  • High-level summaries of the ongoing activities and recent accomplishments of the COA Program including updates from the PRO Consortium, Rare Disease COA Consortium, and eCOA Consortium

Registration: The registration fee will be $500/person* and registration will open in early January.

*Government employees, patients, patient representatives, and patient organization representatives will have the registration fee waived.

share
Facebook