International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium

Affiliations

• ¹ European Organisation for Research and Treatment of Cancer, Brussels, Belgium.
• ² European Organisation for Research and Treatment of Cancer, Brussels, Belgium. Electronic address: [email protected].
• ³ Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ, USA.
• ⁴ Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
• ⁵ Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.
• ⁶ Centre for Patient Reported Outcomes Research, Institute of Applied Health Research and National Institute for Health Research Birmingham Biomedical Research Centre, University of Birmingham, Birmingham, UK.
• ⁷ Patient Relevant Evidence, San Francisco, CA, USA.
• ⁸ Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
• ⁹ Adelphi Values, Bollington, Cheshire, UK.
• ¹⁰ Centre for Health Policy, School of Population and Global Health, University of Melbourne, Melbourne, VIC, Australia.
• ¹¹ Clinic for Child and Adolescent Psychiatry and Psychotherapy, University of Magdeburg, Magdeburg, Germany.
• ¹² School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada.
• ¹³ Boehringer Ingelheim International GmbH, Ingelheim, Germany.
• ¹⁴ Department of Public Health, Bispebjerg Hospital and University of Copenhagen, Copenhagen, Denmark.
• ¹⁵ School of Psychology, University of Sydney, Sydney, NSW, Australia.
• ¹⁶ Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
• ¹⁷ Center for Clinical Studies, University Hospital Regensburg, Regensburg, Germany.
• ¹⁸ College of Pharmacy, University of Arizona, Tucson, AZ, USA.
• ¹⁹ Outcomes Research Branch, Healthcare Delivery Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD, USA.
• ²⁰ Medicines and Healthcare products Regulatory Agency, London, UK.
• ²¹ International Brain Tumour Alliance, Surrey, UK.
• ²² Genentech, Roche Group, San Francisco, CA, USA.
• ²³ Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
• ²⁴ European Centre for Disease Prevention and Control, Surveillance and Response Support Unit, Epidemiological Methods Section, Stockholm, Sweden.
• ²⁵ Department of Neurology and Brain Tumor Center, VU University Medical Center, Amsterdam, Netherlands.
• ²⁶ Institute for Quality and Efficiency in Health Care, Cologne, Germany.
• ²⁷ Health Canada, Ottawa, ON, Canada.
• ²⁸ Department of Neurology, Leiden University Medical Center, Leiden; Department of Neurology, Haaglanden Medical Center, The Hague, Netherlands.
• ²⁹ Leeds Institute of Cancer and Pathology, University of Leeds, St James's Hospital, Leeds, UK; International Society for Quality of Life Research, Milwaukee, WI, USA.