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"Quality of Life Promotional Claims: Methodological Issues and Potential Solutions"
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Program
| 5:30 PM - 5:35 PM | Symposium Objectives
Presented by: Kent Summers PhD, Eli Lilly & Company, Indianapolis, IN, USA, Laurie Beth Burke, MPH, FDA, CDER, Rockville, MD, USA & Jean Paul Gagnon PhD, Aventis Pharmaceuticals, Kansas City, MO, USA |
| 5:35 - 5:40 | Symposium Overview
Panel Leader: Donald Patrick PhD, MSPH, Professor,University of Washington, Seattle, WA, USA |
| 5:40 - 5:50 | Concepts, Definitions, and Domains
Key concept issues will be highlighted such as quality of life, symptoms, functional status, health-related quality-of-life & quality-of-life as measured by preference-based and non-preference-based instruments.
Panelist: Paul Kind MPhil, Senior Research Fellow, University of York, York, UK, and Chair, ISPOR Quality of Life Special Interest Group |
| 5:50 - 6:00 | Study Design & Analysis
Key study design and analysis issues will be highlighted including use of instruments in randomized studies with high internal validity & open label studies with high external validity, use of overall score & domain scores, missing data, and conflicting domains.
Panelist: Ji Zhang PhD, Director, Clinical Biostatistics, Merck Research Laboratories and Nancy Santanello MD, MS, Merck Research Laboratories, West Point, PA, USA and Member, PhRMA Health Outcomes Committee |
| 6:00 - 6:10 | Interpretation of Clinical Studies
Key issues in the interpretation of study results will be highlighted such as: How is clinical significance determined? Should a trial be powered to detect clinical significance up-front?
Panelist: Patrick Marquis MD, Managing Director, MAPI Values, Lyon, France and Member, European Regulatory Issues on Quality of Life Assessment Work Group |
| 6:10 - 6:20 | Promotional Claims
Key issues in the interpretation of study results to support promotional claims will be highlighted such as: If a difference is found to be statistically significant but it is not 'clinically significant,' can a claim be filed?
Panelist: Dennis Revicki PhD, MEDTAP International, Bethesda, MD, USA and Treasurer, International Society for Quality of Life Research |
| 6:20 - 6:30 | Open Discussion
Audience participation. |
| 6:30 - 6:35 | Quality of life Promotional Claim - TICKERPEP® HELPS YOUR CHF PATIENTS GAIN MORE ACTIVE LIVES
Panel Leader: Donald Patrick PhD, MSPH |
| 6:35 - 7:00 | Panel Discussion
Each of the panelists will 5 minutes to present the key issues (domains, study design, study analysis, & interpretation) to consider in the supporting documentation to the FDA to support this claim. |
| 7:00 - 7:30 | Open Discussion
Audience participation.
The Vote
Does the evidence support this promotional claim? |
| 7:30 - 7:35 | Quality of life Promotional Claim - TUMORSTOP® CAN MAINTAIN QUALITY OF LIFE
Panel Leader: Donald Patrick PhD, MSPH |
| 7:35 - 8:00 | Panel Discussion
Each of the panelists will 5 minutes to present the key issues (domains, study design, study analysis, & interpretation) to consider in the supporting documentation to the FDA to support this claim. |
| 8:00 - 8:30 | Open Discussion
Audience participation.
The Vote
Does the evidence support this promotional claim? |
| 8:30 - 9:30 | Reception |
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