Patrick was invited to the Brookings/FDA workshop “Advancing Development and Use of Patient-Reported Outcomes in Drug Development: Near-Term Opportunities”. This meeting was a follow-up from a previous workshop that took place on July 16, which focused on experiences with the FDA’s guidance on PROs, as well as on challenges in capturing the patient voice across the drug development continuum.
This time, sessions focused on:
– I. Developing a Potentially Acceptable Endpoint List: Potential Value and Uses – Implementation Approaches
– II. Identifying Emerging Themes from the Acceptable Endpoints Discussion
– III. Evidentiary Considerations for Making Existing PRO Instruments Fit for Purpose
– IV. Identifying and Prioritizing Next Steps