The NHC’s Clinical Outcome Assessment Webinar Series is Now the Patient-Focused Medical Product Development Webinar Series

By Silke Schoch, Manager, Research & Programs

In November 2018, the National Health Council (NHC) launched a monthly webinar series to educate our members about clinical outcome assessments (COAs), such as patient-reported outcomes. This series was intended to ensure that the NHC membership is prepared to engage in conversations about clinical outcome assessment – closely tied to the Food and Drug Administration’s (FDA) Patient-Focused Drug Development Guidance Series. Since 2018, we have hosted 12 webinars:

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

With the new year, we are expanding the scope of our webinar series to include other related topics that do not necessarily fit under the COA umbrella. Now known as the Patient-Focused Medical Product Development (PFMPD) series, it will still include COA topics, but also topics related to patient engagement in both drug and medical device development. Examples of upcoming topics include patient preference research and patient engagement in clinical trial design.

We are very excited about our first webinar in the series, which will feature guest speakers, Debbie Drell, Director of Membership, at the National Organization for Rare Diseases (NORD), and Andrea Furia-Helms, Director, Patient Affairs Staff, at the U.S. Food and Drug Administration (FDA). They will delve into their collaboration on Rare Disease Patient Listening Sessions. You can sign up for the webinar here.

Also, be sure to check out our library of real-world case examples of patient engagement in medical product development here.