Great news! I am pleased to announce that RFR has entered into a formal partnership with Dr. Jennifer Miller, TREND Community, Ardea Outcomes and COMBINEDBrain to begin the process of creating a new Clinical Outcome Assessment (COA) tool.
This process will involve the above-mentioned parties but also the PWS community and its key opinion leaders (KOLs). Stay tuned for opportunities to participate!
Throughout this process, Trend Community will be actively engaged with the FDA to ensure that the developing COA will meet regulatory expectations. Phase 1 of this project is underway now and includes Protocol Submission to IRB and Stakeholder Engagement.
RFR would like to thank every person who has fundraised, donated or in any way supported this most critical project. Your hard work and effort have enabled us to begin this process. We feel strongly that successfully creating a new COA will prove to be a game changer for our community!