Patrick was invited to the Brookings/FDA workshop “Enhancing the Development and Use of Patient-Reported Outcomes in Drug Development”, where the experience with FDA Guidance on PROs was discussed.
Sessions focused on:
– 1. Evidentiary Standards
– 2. Standardizing Communication Processes
– 3. Challenges to Capturing the Patient Voice Across the Drug Development
– 4. Next Steps in Promoting the Development and qualification of PROs