Introduction
The role of health-related quality of life (HrQoL) evaluation in the drug regulatory process is an evolving story. Sometimes it may seem that the advances in drug development far outweigh the social and political processes by which drugs are evaluated for efficiency and effectiveness. The consuming public would like an ever reduced gap, bridged with lightening speed, between the laboratory and the street. Health care managers want a cost-efficient formulary that is competitive and attractive to consumers in market systems or legislators and administrators in state-run systems. The pharmaceutical industry would like the pipeline to succeed for its investors and its secured future. And regulators—overseers of public safety and gatekeepers to stamped approval of efficacy and effectiveness—face the challenge of sifting through the submitted evidence and making judgments that influence all the stakeholders.

The Issues
To make the challenge of evaluating promotional claims as clear and as realistic as possible, this Quality of Life Symposium is organized into two sections. First, in the very short time of 10 minutes each, panelists will review key issues in four selected areas. Each panelist will give a distilled list of issues and definitions to set the stage, after which we shall have a brief 10 minute discussion with audience questions. The four selected areas are:

• Concepts, Definitions, and Domains (Dr. Paul Kind)
• Study Design and Analysis (Drs. Ji Zhang and Nancy Santanello)
• Interpretation (Dr. Patrick Marquis)
• Promotional Claims (Dr. Dennis Revicki)

The Promotional Claims
FDA staff fabricated two promotional claims with supporting information. The panelists then developed a dataset summary to elicit audience discussion on the key issues. The two promotional claims, supporting information, and dataset summary follow. The two 'fabricated' promotional claims are:

The Discussion
After a brief description of each promotional claim and study dataset summary, each panelist will have 5 minutes to discuss the relevant issues within their selected area that is germane to the claim. The audience will then have 30 minutes to discuss and question the panelists on each promotional claim.

The Vote
The audience will then vote on "Should this evidence support the promotional claim?"

Note: Not every detail supporting the claim can be included in the example, so please accept the information provided as the information available for the discussion. Suggestions for further documentation will be welcomed, but please remember these promotional claims are simulated.

Disclaimer: ISPOR and the symposium planning committee are neither endorsing nor critiquing the health-related quality of life questionnaires selected to illustrate the fabricated promotional claims in this program. The use of real quality of life assessment instruments is for teaching purposed only. All data were fabricated to stimulate discussion.

We hope you enjoy this symposium.