• Madeline Pe, Ahu Alanya, Ragnhild Sorum Falk, Cecilie Delphin Amdal, Kristin Bjordal, Jane Chang, Paul Cislo, Corneel Coens, Linda Dirven, Rebecca M Speck, Kristina Fitzgerald, Jayne Galinsky, Johannes M Giesinger, Bernhard Holzner, Saskia Le Cessie, Daniel O'Connor, Kathy Oliver, Vivek Pawar, Chantal Quinten, Michael Schlichting, Jinma Ren, Satrajit Roychoudhury, TaphoornMartin J BMJBDepartment of Neurology, Leiden University Medical Center, Leiden, Netherlands; Department of Neurology, Haaglanden Medical Center, The Hague, Netherlands., Galina Velikova, Lisa M Wintner, Ingolf Griebsch, Andrew Bottomley, and SISAQOL-IMI Consortium.
• Quality of Life Department, European Organisation for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium. Electronic address: madeline.pe@eortc.org.
• Lancet Oncol. 2023 Jun 1; 24 (6): e270e283e270-e283.

AbstractPatient-reported outcomes (PROs), such as symptoms, functioning, and other health-related quality-of-life concepts are gaining a more prominent role in the benefit-risk assessment of cancer therapies. However, varying ways of analysing, presenting, and interpreting PRO data could lead to erroneous and inconsistent decisions on the part of stakeholders, adversely affecting patient care and outcomes. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI) Consortium builds on the existing SISAQOL work to establish recommendations on design, analysis, presentation, and interpretation for PRO data in cancer clinical trials, with an expanded set of topics, including more in-depth recommendations for randomised controlled trials and single-arm studies, and for defining clinically meaningful change. This Policy Review presents international stakeholder views on the need for SISAQOL-IMI, the agreed on and prioritised set of PRO objectives, and a roadmap to ensure that international consensus recommendations are achieved.Copyright © 2023 Elsevier Ltd. All rights reserved.

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