Clinical Outcome Assessment (COA) Webinar Series

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: 

View The PFMPD Webinar Series Recordings

The NHC’s Patient-Focused Medical Product Development (PFMPD) series builds upon our Clinical Outcome Assessment series.