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PATIENT-REPORTED OUTCOMES ‘PRO’ SYMPOSIUM CONCEPTUAL AND METHODOLOGICAL ISSUES

Hyatt Regency Crystal City
Arlington, Virginia, USA

Prior to the ISPOR 7th Annual International Meeting

Free! No registration required!

Sunday, May 19, 2002 6:30 – 8:30 pm
Followed by a Reception
Sponsored by:
FDA, ISPOR and PhRMA Health Outcomes Committee

This program was developed in cooperation with the Patient-Reported Outcomes Harmonization Group*

Background:
Data to evaluate the efficacy or effectiveness of treatment can come from a variety of sources, including laboratory tests, clinician evaluation, and the patients themselves. In the outcomes research community, the term "patient-reported outcomes (PRO)" is used to refer to a host of outcomes that can be provided only by the patient. Examples of these outcomes include symptom severity, perception of daily functioning, feelings of well being, global impressions of the impact of treatment on daily life, satisfaction with treatment, and health-related quality of life. The role that PROs can and should play in evaluating the efficacy of pharmaceuticals and medical devices and the means by which these outcomes are communicated to clinicians and consumers are subjects of much discussion and debate.
Over the past 2 years, representatives from ISPOR, PhRMA HOC, ISOQOL and ERIQA (now collectively called the *Patient-Reported Outcomes (PRO) Harmonization Group) have been participating in discussions with the FDA about the use of health-related quality of life (HRQL) and, more recently, patient reported outcomes (PRO) in pharmaceutical research and communications. An overview of PRO Harmonization Group initiatives, meetings, presentations are at the PRO Harmonization Group website at www.pro-harmonization-group.com.This symposium will highlight activities of the PRO Harmonization Group, and provide an overview of discussions related to conceptual and methodological issues with specific examples.

PROGRAM

6:30 – 6:35 PM

INTRODUCTION AND AWARD PRESENTATION
Presenter: Kati Copley-Merriman MS, MBA, Director of Outcomes Research, Pfizer Pharmaceutical Group, Ann Arbor, MI, USA and Chair, PhRMA Health Outcomes Committee
Awardee: Catherine Acquadro MD, ERIQA Group Coordinator, Mapi Research Institute, Lyon, France

6:35 – 6:40 PM

OVERVIEW OF THE PRO HARMONIZATION GROUP EFFORTS
Speaker & Moderator:
Jean Paul Gagnon PhD, Director, Public Policy, Aventis Pharmaceuticals, Bridgewater, NJ, USA

6:40 – 6:55 PM

‘PRO’ CONCEPTUAL ISSUES
Speaker:
Margaret Rothman PhD, Executive Director, Health Economics Johnson and Johnson Pharmaceutical Research and Development, Raritan, NJ, USA

6:55 – 7:10 PM

‘PRO’ METHODOLOGICAL ISSUES
Speaker:
Nancy Santanello MD, MS, Executive Director, Epidemiology, Merck Research Laboratories, West Point, PA, USA

7:10 – 7:40 PM

SPECIFIC FDA ISSUES

7:10 – 7:25 PM

INSTRUMENT DEVELOPMENT: WHAT ARE THE STANDARDS?
Speaker:
Donald Patrick PhD, MSPH, Professor, University of Washington, Seattle, WA, USA

7:25 – 7:40 PM

INTERPRETING CHANGES THAT ARE NOT CONSISTENT BETWEEN OUTCOMES
Speaker: Joyce Cramer BS, Associate Research Scientist, Yale University School of Medicine, West Haven, CT, USA

7:40 – 8:00 PM

FDA PERSPECTIVE of ‘PRO’
Speaker:
Laurie Beth Burke RPh, MPH, Chief, Regulatory Review Branch, FDA, CDER, DDMAC, Rockville, MD, USA

8:00 – 8:30 PM

 PANEL AND AUDIENCE DISCUSSION

8:30 – 9:30 PM

ANNOUNCEMENTS AND RECEPTION
Kati Copley-Merriman MS, MBA, Director of Outcomes Research, Pfizer Pharmaceutical Group

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