NHC’s New Initiative on Clinical Outcome Assessments

By: Dr. Elisabeth Oehrlein, Senior Director, Research and Programs

In fall 2018, the NHC launched a new educational initiative on clinical outcome assessment (COAs). The webinar series is 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 – one of these focuses specifically on identifying outcomes that are important to patients and another focuses on COAs 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).

Patient-Reported Outcome Measures (PROs) – Report that comes from the patient about the status of a patient’s health condition without amendment or interpretation of the patient’s report by a clinician or anyone else.

Clinician-Reported Outcome Measures (ClinROs) – Report that comes from a trained health-care professional after observation of a patient’s health condition.

Observer- Reported Outcome Measures (ObsROs) – Observation by someone other than the patient or a health professional. This may be a parent, spouse, or other non-clinical caregiver who is in a position to regularly observe and report on a specific aspect of the patient’s health.

Performance Outcome Measures (PerfOs) – Based on a task(s) performed by a patient according to instructions that is administered by someone trained such as a health care professional.

We have to date hosted four webinars in this series, which are archived on our website. Stay tuned, as we will also be publishing future blogs focusing on each of the topics covered in the webinars. Upcoming webinars include:

March 20, 2019 at 1 p.m. ET ­­– What Do We Mean by Validation of a Measure? This webinar will feature Dr. Eleanor Perfetto, Executive Vice President of Strategic Initiatives at the National Health Council. Please register here to receive webinar information.