Patient-reported Outcomes: the Example of Health-related Quality of Life—a European Guidance Document for the Improved Integration of Health-related Quality of Life Assessment in the Drug Regulatory Process

*Members of the European Regulatory Issues on Quality of Life Assessment (ERIQA) Group: Dr. Neil Aaronson, The Netherlands Cancer Institute, The Netherlands; Dr. Catherine Acquadro, Coordinator of the ERIQA Group, Mapi Research Institute, France; Dr. Giovanni Apolone, Mario Negri Institute, Italy; Dr. Harry Burns, Dalian House, Glasgow, UK; Dr. Olivier Chassany, Hôpital Saint-Louis, France; Dr. Gianfranco De Carli, GlaxoWellcome, Italy; Dr. Dominique Dubois, Janssen Pharmaceutica N.V., Belgium; Steve Fullerton, Cedars-Sinai Health System/Zynx Health Incorporated, US; Dr. Bernard Genesté, Aventis, France; Dr. Asha Hareendran, Pfizer Central Research, UK; Bernard Jambon, Mapi Group, France; Dr. Patrick Marquis, Mapi Values, US; Dr. Pauline McNulty, ICOM Health Economics, Johnson & Johnson, US; Dr. Caroline Miltenburger, SCHERING AG, Germany; Dr. Annoesjka Novak, NV Organon, The Netherlands; Dr. Margaret L. Rothman, Janssen Research Foundation, US; Dr. Pierre Philippe Sagnier, Bayer plc, Medical Affairs, UK; Dr. François Schubert, GlaxoWellcome Research & Development, UK; Dr. Soren E. Skovlund, Novo Nordisk, Denmark; Dr. Marianne Sullivan, Göteborg University, Sweden; Dr. Marc Tomas, Outcomes Research BMS, Belgium; Dr. Suzanne Wait, Bristol Myers Squibb, UK; Dr. Ingela Wiklund, AstraZeneca R&D, Sweden; and Dr. G. Rhys Williams, Knoll Pharmaceutical Company, US. Reprint address: Dr. Olivier Chassany, Direction de la Politique Médicale de l’AP-HP, Délégation Régionale à la Recherche Clinique, Hôpital Saint-Louis, 1 Avenue Claud Vellefaux, 75475 Paris Cedex, 10, France. E-mail: [email protected].