- The Sentinel System— An Overview of FDA’s Tools for Assessing Medical Product Safety and Gathering Real-World Evidence
- Introducing the NHC’s Rubric to Capture the Patient Voice
- IRS Policy on High-Deductible Health Plans Impacting Americans with Chronic Conditions
- Three-part webinar series on Patient Engagement in Value Assessment
- Three-part webinar series on Alternative Payment Models
- 21st Century Cures: Requirement on Patient Experience Data and Related Information
- Clinical Outcome Assessments: 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?
- Successful COAs: 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
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).
The Sentinel System— An Overview of FDA’s Tools for Assessing Medical Product Safety and Gathering Real-World Evidence
August 21, 2019 - This webinar provides an overview of Sentinel’s growing capabilities and value in regulatory decision-making. Sentinel enhances the FDA’s ability to proactively monitor the safety of medical products after they have reached the market and complements the Agency’s existing spontaneous reporting systems. Particular focus is on Sentinel's role in safety surveillance and use of real-world data (RWD) and real-world evidence (RWE). The webinar also highlights the efforts and objectives of a patient representative-led stakeholder engagement work group that developed tailored messages for diverse audiences on the broadened uses of Sentinel.
July 11, 2019 - The webinar was in conjunction with the release of the NHC’s Rubric to Capture the Patient Voice the same day. The Rubric is a tool that the patient community or any other health care stakeholder can use to evaluate attributes of patient centeredness and to guide them on meaningful patient engagement throughout any activity they might undertake.
COA Series: 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.
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.
COA Series: 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).
March 20, 2019 - This webinar featured Dr. Eleanor Perfetto, Executive Vice President, Strategic Initiatives, at the National Health Council.
Feb. 20, 2019 - This webinar featured T. Rosie Love, MPH, University of Maryland School of Pharmacy, Dept. Pharmaceutical Health Services Research
Jan. 17, 2019 - This webinar featured Ashley F. Slagle, MS, PhD, Principal, Aspen Consulting, LLC.
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.
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.
The NHC hosted a webinar on June 26, 2018 with top value-based insurance-design expert Dr. A. Mark Fendrick. The one-hour webinar focused on a recent study that examines how current IRS policy on high-deductible health plans (HDHPs) and health savings accounts (HSAs) impacts Americans living with chronic conditions. Dr. Fendrick presented findings of the study and participated in an audience question-and-answer session. This webinar was sponsored by the National Pharmaceutical Council. Dr. Mark Fendrick is the Director, University of Michigan Center for Value-Based Insurance Design and a Professor of Internal Medicine in the School of Medicine and a Professor of Health Management and Policy in the School of Public Health at the University of Michigan.
- Part 1: An Overview of Value Frameworks
- Part 2: Introduction to Health Economics & Value Assessment
- Part 3: How the Patient Community Can & Should Be Engaged
As innovative payment models continue to evolve and transform the US health care system, patients must be engaged and activated. This webinar series is specifically developed for the patient community.