Measuring What Matters to Patients: Use of Patient-Reported Outcome Assessments in the Regulatory Context

Speakers: R.J. Wirth and Rikki Mangrum, Vector Psychometric Group

"Patient-Reported Outcomes" might sound simple, but FDA recently released a suite of 4 (FOUR!) guidance documents on "Patient-Focused Drug Development" (PFDD) on how to appropriately design and use these types of clinical outcome measures to support safety, efficacy, and/or utility of a drug, biological product or medical device.  What is in all of those guidance documents, and why do we need them?

Join NCRAF for a special seminar on this topic by R.J. Wirth (CEO/co-Founder) and Rikki Mangrum (Director of Patient-Centered Research) of Vector Psychometric Group.  Their talk will include the following objectives:

• Definitions of “what matters to patients” and how patient experiences are studied and interpreted for PROM development
• Types of evidence needed to support the selection of a patient-centered outcome assessment and justification of its use in the regulatory context (“fit-for-purpose”)
• Practical guidance for identifying, selecting, and evaluating an outcome assessment, or how to know if a new assessment may be required

Speaker biographies:

R.J. Wirth is the Chief Executive Officer, co-Founder, and a managing partner at Vector Psychometric Group, LLC. Dr. Wirth received his PhD in quantitative psychology / psychometrics from the historic LL Thurstone Psychometric Laboratory at University of North Carolina – Chapel Hill. Prior to leading VPG, Dr. Wirth held research positions at the Frank Porter Graham Child Development Institute at UNC and in the School of Medicine at the University of Washington. For nearly two decades, Dr. Wirth has collaborated widely within the pharmaceutical and medical device industries to develop and/or evaluate the measurement properties of clinical outcome assessments and was awarded (as co-PI) one of the first FDA-funded CDER pilot program grants: Standard core clinical outcome assessments and their related endpoints.​ Dr. Wirth has authored numerous peer-reviewed publications on such topics as item factor analysis, structural equation modeling, validity, as well as various aspects of scale development appearing in outlets such as Headache, Health Psychology, Medical Care, Psychological Assessment, Psychological Methods and Quality of Life Research. He has participated as an invited expert speaker on multiple FDA panels and Industry advisory boards focused on PRO/COA development. 

Rikki Mangrum is Director of Patient-Centered Research at Vector Psychometric Group, LLC. She has an MLS in Library and Information Science from the University of North Carolina at Chapel Hill. Ms. Mangrum has extensive experience with designing and conducting qualitative and mixed-method studies related to patient experiences with health and medical treatment. She has interviewed hundreds of people living with chronic illnesses and is an expert in qualitative data collection, analysis, and reporting in support of measurement development and testing. Ms. Mangrum also has more than 30 years’ experience in designing and executing literature and landscape reviews. She has published in journals such as Headache, Health Affairs, Health Expectations, Health Services Research, and the Journal of General Internal Medicine. She has subject matter expertise in post-acute and long-term healthcare delivery, chronic and progressive illness, and patient and family engagement, and is a senior editor for The Qualitative Report, a leading source of information on the latest developments in qualitative inquiry.

EVENT DETAILS AND REGISTRATION:

For in-person attendees, there is a networking reception from 5:30-6:30.  

The hybrid seminar presentation will be held from 6:30-8, including an open floor for audience questions. 
Thank you to the North Carolina Biotechnology Center for making this venue available to NCRAF through their "Exchange Group" program!

Register for this event below. The event is free for all NCRAF members.  For non-members, registration is $20.

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