The National Health Council hosted a 12-part webinar series on Clinical Outcome Assessment (COA), intended to help the patient community better equip itself to engage with regulators, researchers, and other stakeholders to drive patient centeredness across health care research, but especially medical product development.

As a part of the 21st Century Cures legislation and the Prescription Drug User Fee Act VI Reauthorization, the FDA committed to develop four guidances on Patient-Focused Drug Development – focusing on identifying outcomes that are important to patients and on COAs more specifically.

COAs “measure a patient’s symptoms, overall mental state, or the effects of a disease or condition on how the patient functions” – in short, COAs tell you something about how a patient feels or functions. The COA umbrella includes several different types of outcomes: patient-reported outcomes (PROs), clinician-reported outcomes (ClinROs), observer-reported outcomes (ObsROs), and performance outcomes (PerfOs).

 View the webinar recordings here: 

• Patient Reported Outcomes and Patient Centered Outcomes
• FDA’s Roadmap to Patient-Focused Outcome Measurement in Clinical Trials 
• Untangling the Terms: Endpoints, Items, Outcomes, PRO’s, PROMs, PRO-PMs 
• Successful COAs: It All Starts With the “Concept of Interest” and “Context of Use” 
• What Do We Mean by Validation of a Measure? 
• Measuring Patient Experiences: Distinguishing Between Patient-Reported Outcomes and Patient Preferences 
• Lessons Learned from a Patient Group’s Experience Developing a PRO 
• What is the Difference Between Health-Related Quality of Life (HRQoL) and Patient-Reported Outcomes? 
• Core Outcome Sets 
• What are Clinician-Reported Outcomes (ClinROs)? 
• Clinical Outcome Assessment: Build New or Adapt Old? 
• 21st Century Cures: Requirement on Patient Experience Data and Related Information