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
Lumanity will be attending the meeting in Bethesda, MD.
Connect with our staff or schedule a time to meet during the meeting by reaching out to contact@lumanity.com.