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Trk 13: CER-Glob Health Econ [clear filter]
Monday, June 27

10:45am EDT

#139: Measuring the Impact and Influence of Patient Input on Regulatory and Health Technology Assessment Decision Making: What Are the Key Considerations?
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-568-L04-P; CME 1.25; IACET 1.25; RN 1.25

This interdisciplinary session will explain how, with increased patient engagement, both regulatory and health technology assessment agencies need to be able to assess and report on how patient input is being utilized and how it is informing the decision process.

Learning Objectives

Discuss how health technology assessment agencies and regulators engage with patients so that the assessment and decision making is utilizing patients’ viewpoints; Identify the challenges that agencies face to ensure that the patient’s viewpoints are embedded into their decision processes; Assess the types of parameters agencies are using to measure the impact patient engagement is having on their processes and decision making.


Neil McAuslane, PhD, MSc


FDA Perspective
Theresa M. Mullin, PhD

Empowering Patients as Organizational Change Agents
Durhane Wong-Rieger, PhD, MA

HTA Perspective
Victoria Thomas, MSc

avatar for Neil McAuslane

Neil McAuslane

Director, Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Neil McAuslane is Director of the Centre for Innovation in Regulatory Science (CIRS, previously CMR International) and works in the area of regulatory and HTA strategy and R&D performance. Prior to joining CMR International in 1988, Neil completed his PhD degree in Clinical Pharmacology... Read More →

avatar for Theresa Mullin

Theresa Mullin

Associate Director for Strategic Initiatives, CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads efforts including Patient-Focused Drug Development, Rare Disease Cures Accelerator, and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee... Read More →
avatar for Victoria Thomas

Victoria Thomas

Head of Public Involvement, Public Involvement Programme, National Institute For Health and Care Excellence (NICE)
Victoria Thomas has run the Public Involvement Programme at NICE since 2009, and has been with the Programme since 2001. Following a degree in Art History, Victoria has worked exclusively in the public and voluntary sector, specialising in healthcare quality improvement activities... Read More →
avatar for Durhane Wong-Rieger

Durhane Wong-Rieger

President and Chief Executive Officer, Canadian Organization For Rare Disorders (CORD)
Durhane Wong-Rieger, PhD, is President, Institute for Optimizing Health Outcomes; President; Canadian Organization for Rare Disorders; Chair, Consumer Advocare Network; Past-Chair, International Alliance of Patient Organizations; Co-Chair, HTAi Patient / Citizen Involvement IG; Board... Read More →

Monday June 27, 2016 10:45am - 12:00pm EDT
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Tuesday, June 28

10:30am EDT

#224: Identifying Patient-Centered Outcomes for Use in Observational Research: Why and How
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-569-L01-P; CME 1.00; IACET 1.00; RN 1.00

The inclusion of valid, reliable patient-centered outcomes is increasingly important for observational studies. Yet, identifying such outcomes is challenging. This session will discuss resources for identifying and developing outcome measures.

Learning Objectives

Describe the need for standardized or harmonized outcome measures for use in observational clinical research studies; Identify challenges to identifying valid, reliable, standardized outcome measures for use in new studies; Discuss examples of disparate outcome measure definitions; Summarize resources that can assist researchers in selecting appropriate outcome measures.


Richard Gliklich, MD


Elise Berliner, PhD


Elise Berliner

Director, Technology Assessment Program, Agency For Healthcare Research and Quality (AHRQ)
Dr. Berliner is the Director of the Technology Assessment Program at the Agency for Healthcare Research and Quality (AHRQ). The Technology Assessment Program provides technology assessments to the Centers for Medicare & Medicaid Services (CMS) to inform Medicare coverage decisions... Read More →
avatar for Richard Gliklich

Richard Gliklich

Chief Executive Officer, Better Outcomes
Dr. Richard Gliklich is the CEO of Better Outcomes Corporation. He was founder and CEO of Outcome Sciences, a health information and services company. He led the company from inception through its acquisition by Quintiles. A graduate of Yale University and Harvard Medical School and... Read More →

Tuesday June 28, 2016 10:30am - 11:30am EDT
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 13: CER-Glob Health Econ, Session

2:00pm EDT

#247: Fit for Purpose and Modern Validity Theory in PROs
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-575-L01-P; CME 1.25; IACET 1.25; RN 1.25

Fit for purpose is an important consideration in patient-reported outcomes (PROs). This session will provide an overview of current validity theory and the thinking on the idea of fit for purpose, and situate the concept of fit for purpose within the broader topic of validity.

Learning Objectives

Articulate key concepts in modern psychometric validity theory; Describe the notion of fit for purpose as it relates to patient/clinician reported outcomes.


R.J. Wirth, PhD


Current Thinking in Validity Theory
Jonathan D Rubright, PhD, MSc

Validity: US Regulatory Considerations
Ashley F. Slagle

How Does Fit for Purpose Fit in Validity Theory?
Michael Edwards, PhD, MA

avatar for R.J. Wirth

R.J. Wirth

President, Vector Psychometric Group, LLC
R.J. Wirth is President and managing partner at VPG. He trained in the L. L. Thurstone Psychometric Lab, receiving his PhD in Quantitative Psychology from the University of North Carolina – Chapel Hill. His research focuses on modern psychometrics with an emphasis on measurement... Read More →


Michael Edwards

Managing Partner, Vector Psychometric Group, LLC
Michael C. Edwards is a managing partner at VPG. He earned his PhD in Quantitative Psychology from the University of North Carolina – Chapel Hill. His research is generally focused on modern psychometrics with specific emphases on item response theory, factor analysis, and computerized... Read More →
avatar for Jonathan Rubright

Jonathan Rubright

Psychometrician, National Board of Medical Examiners
As psychometrician at the National Board of Medical Examiners, Jonathan shoulders operational responsibility for high-stakes medical exams and leads exam-related research. Prior to NBME, he worked at AICPA and also evaluated tests to support research on human subjects with impaired... Read More →
avatar for Ashley Slagle

Ashley Slagle

Principal, Scientific and Regulatory Consulting, Aspen Consulting, LLC
Dr. Slagle is a scientific and regulatory expert, providing advice on patient centered drug development to drug product developers. Formerly with the US FDA Clinical Outcome Assessment (COA) Staff, her experience includes over 15 years of policy analysis and outcomes research, including... Read More →

Tuesday June 28, 2016 2:00pm - 3:15pm EDT
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 13: CER-Glob Health Econ, Session