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"Quality of Life Promotional Claims: Methodological Issues and Potential Solutions"
co-sponsored by
ISPOR and PhRMA Health Outcomes Committee and the US Food and Drug Administration
Supported by funding from:
Aventis Pharmaceuticals
Bristol-Myers Squibb
Eli Lilly and Company
Glaxo Wellcome Inc.
Johnson & Johnson Health Economics
Merck Research Laboratories
Novartis Pharmaceuticals
Parke Davis Pharmaceutical Research
Pharmacia
Pfizer Inc.
Pharmaceutical Research Manufacturers Association [PhRMA]
Introduction
ISPOR, PhRMA HOC, ISOQOL with members of the FDA DDMAC and HRQL Work Group have been working together to identify quality of life labeling and promotional claims methodological issues for drugs, biologicals, and devices. The issues identified are at the ISPOR website at www.ispor.org under ISPOR Working Paper Series. This symposium will provide an opportunity for quality of life researchers and government regulators to discuss solutions to these issues.
Background
Issues related to the difficulties in quality of life research and interpretation by regulatory bodies has been discussed in numerous venues. To move forward in the application of quality of life research, we need to better understand acceptable scientific solutions to these issues.
Goal
The goal for this symposium is to provide health outcomes researchers the opportunity to develop a clearer understanding of the scientific evidence needed to support quality of life promotional claims.
Objectives
Our first objective is to describe four categories of the key issues that have been identified in various venues as important to the conduct of quality of life research. Thus, we will examine:
- Concepts, domains and terminology related to the use of terms such as health status, quality of life and health-related quality of life;
- Study design and analysis, with a focus on appropriate statistical analysis, multiple significance testing, and missing data;
- Interpretation, including the application of current methods for determining the clinical significance of differences in outcomes that achieves statistical significance.
- Promotional claims related to quality of life outcomes of pharmaceutical therapy
The second objective of the symposium is to identify potential methodologic solutions to these four issues. An examination of what might constitute sufficient evidence to support quality of life promotional claims will occur during discussions of case examples that could arrive for review at
regulatory and advisory organizations.
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