Clinical Outcome Assessment


There is growing interest in clinical outcome assessments, such as patient-reported outcomes, and patient-centeredness across the health care ecosystem. For example, in 2019, the Food and Drug Administration will release two new guidance documents on clinical outcome assessment. The NHC seeks to ensure that the NHC membership is prepared to engage in conversations about clinical outcome assessment. We will post information about upcoming and past webinars, along with in-person meetings and other resources on this page. If you would like to suggest a topic, please submit one.

Upcoming webinars:

Stay tuned for updates on webinars in 2020.

Past webinars:

21st Century Cures - Requirement on Patient Experience Data and Related Information

Nov. 8, 2019 -  This webinar featured Annie Kennedy, Chief of Policy and Advocacy at the EveryLife Foundation, and Meghana Chalasani, Senior Research Analyst for the Patient-Focused Drug Development (PFDD) Program in FDA’s Center for Drug Evaluation and Research (CDER). Read the blog.


Clinical Outcome Assessments: Build New or Adapt Old?

Oct. 10, 2019 - This webinar featured Stacie Hudgens, MA, Chief Executive Officer, Strategic Lead, Regulatory & Access at Clinical Outcomes Solutions. Learn more on our blog.

What are Clinician-Reported Outcomes (ClinROs)?

Sept. 12, 2019 - This webinar featured John H. Powers, MD, FACP, FIDSA [C], Professor of Clinical Medicine, George Washington University School of Medicine. Clinician-reported outcome (ClinRO) measures are a type of clinical outcome assessment. ClinROs are reports that come from a trained health care professional after personally observing a patient’s condition. A ClinRO measure involves clinical judgment and interpretation of what the clinician sees in terms of signs, behaviors, or other physical aspects thought to be related to the illness. ClinRO measures can never directly assess symptoms that are known only to the patient, for example, pain or fatigue. This session provides an overview of ClinROs and how they are related to what patients report as being most important to them. Read the blog.

Core Outcome Sets

July 15, 2019 - This webinar featured Donna Messner, President & CEO at the Center for Medical Technology Policy. Learn more on our blog.

What is the Difference Between Health-Related Quality of Life (HRQoL) and Patient-Reported Outcomes?

June 10, 2019 - This webinar featured Laurie Burke, MPH, Founder of the LORA Group, LLC. Read the blog.


Lessons Learned from a Patient Group’s Experience Developing a PRO

May 14, 2019 - This webinar featured Dory Kranz, President & CEO of the National Alopecia Areata Foundation. In this webinar, you will learn about a case study of the process that a patient advocacy group goes through as they develop a patient reported outcome (PRO) measure. Read the blog.


Measuring Patient Experiences: Distinguishing Between Patient-Reported Outcomes and Patient Preferences

April 18, 2019 - This webinar featured Pauline McNulty and Bennett Levitan of Johnson & Johnson. In this webinar you will learn about the differences between patient-reported outcomes and patient preferences. Patient-reported outcomes or PROs provide insights on how patients feel and function in their everyday lives. Patient preferences, on the other hand, reflect what patients choose when presented with different options (e.g., treatment attributes, desired outcomes). Learn more on our blog.


What Do We Mean by Validation of a Measure?

March 20, 2019 - This webinar featured Dr. Eleanor Perfetto, Executive Vice President, Strategic Initiatives, at the National Health Council. 



Successful COAs: It all starts with the “concept of interest” and “context of use”

Feb. 20, 2019 - This webinar featured T. Rosie Love, MPH, University of Maryland School of Pharmacy, Dept. Pharmaceutical Health Services Research. Read the blog about this webinar.

Clinical Outcome Assessment Webinar Series: Untangling the Terms: Endpoints, Items, Outcomes, PRO’s, PROMs, PRO-PMs

Jan. 17, 2019 - This webinar featured Ashley F. Slagle, MS, PhD, Principal, Aspen Consulting, LLC. Read more on our blog.


FDA’s Roadmap to Patient-Focused Outcome Measurement in Clinical Trials

Dec. 7, 2018 - In patient-centered research and care, we focus on the outcomes most important to patients. Often, patients tell us that what is most important to them is how they feel and how well they function in their everyday lives. To capture data on these outcomes in clinical trials, measures must first be developed. This webinar introduces participants to a document, the Roadmap, developed by the Clinical Outcome Assessment (COA) team at the Food and Drug Administration. The Roadmap helps researchers develop tools that measure outcomes that matter most to patients. Read the blog.

Patient Reported Outcomes and Patient Centered Outcomes

Nov. 7, 2018 - In patient-centered research and care, we focus on the outcomes most important to patients. Often, patients tell us that what is most important to them is how they feel and how well they function in their everyday lives. These outcomes are referred to in research as patient-reported outcomes or PROs. So, what is the difference between a patient-centered outcome and a patient-reported outcome? Are they the same? The answer is: No, they are not the same! In this webinar, presented by Dr. Eleanor Perfetto, you will learn about the difference between patient-centered outcomes and patient-reported outcomes, and why we need patient-centered PROs in research and care. Read the blog.