Co-sponsored by ISPOR, PhRMA Health Outcomes Committee, and the US Food and Drug Administration, the May 21, 2000 Quality-of-Life Symposium, "Quality of Life Promotional Claims: Methodological Issues and Potential Solutions," attracted nearly 400 people including members of the public. The goal of the event was to provide health outcomes researchers with the chance to develop a clearer understanding of the scientific evidence needed to support quality of life promotional claims. The symposium was organized into two sections. First, key issues were presented: definitions and concepts, study design, study interpretation, and use of studies in justifying promotional claims. This was followed by audience Q&A. Second, fabricated promotional claims (TICKERPEP and TUMORSTOP) were presented, discussed by the panel, then opened to audience discussion. After each, a vote was taken to determine if the evidence supported the promotional claim. Organizers were Kent Summers PhD, (ISPOR), Eli Lilly & Company, Indianapolis, IN; Laurie Beth Burke MPH, (FDA), Rockville, MD; and Jean Paul Gagnon PhD, (PhRMA HOC), Aventis Pharmaceuticals, Kansas City, MO. At the podium were Donald Patrick PhD, MSPH, Professor, University of Washington, Seattle, WA; Paul Kind MPhil, Senior Research Fellow, University of York, UK, and Chair, ISPOR Quality of Life Special Interest Group; Ji Zhang PhD, Director, Clinical Biostatistics, Merck Research Laboratories, Rahway, NJ; Nancy Santanello MD, MS, Merck Research Laboratories, West Point, PA and Member, PhRMA Health Outcomes Committee; Patrick Marquis MD, Managing Director, MAPI Values, Lyon, France and Member, European Regulatory Issues on Quality of Life Assessment Work Group; Dennis Revicki PhD, MEDTAP International, Bethesda, MD and Treasurer, International Society for Quality of Life Research. The strong attendance at this event demonstrates the timeliness of this topic.