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Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures

2023; Elsevier BV; Volume: 24; Issue: 6 Linguagem: Inglês

10.1016/s1470-2045(23)00157-2

1474-5488

Madeline Pe, Ahu Alanya, Ragnhild Sørum 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, Martin Taphoorn, Galina Velikova, Lisa M. Wintner, Ingolf Griebsch, Andrew Bottomley, Cat N. Bui, Nnadozie Emechebe, Rajesh Kamalakar, Elektra J. Papadopoulos, Kavita Sail, Rohini Sen, Sean Turner, Kim Cocks, Jaap C. Reijneveld, Christoph Gerlinger, Karen Keating, Yun Su, Birgit Wolf, Miaomiao Ge, Anders Ingelgaard, Barbara Peil, Maarten Voorhaar, Brendon Wong, Gracia Dekanic Arbanas, Karin Kuljanić, Duška Petranović, Ivana Rede, Juan Ignacio Arrarás, Stephen Joel Coons, Sonya Eremenco, Lindsey Murray, Bryce B. Reeve, Corinne S de Vries, Ralf Herold, Francesco Pignatti, Abigirl Machingura, Francesca Martinelli, Jammbe Z. Musoro, Martine Piccart, Jorge Barriuso, Nathan I. Cherny, Urania Dafni, Elisabeth G.E. de Vries, Bishal Gyawali, Barbara Kiesewetter, Sjoukje F. Oosting, Felipe Roitberg, Gerhard Rumpold, Felix Schoepf, Michael Tschuggnall, Jennifer A. Black, Maxime Sasseville, Katherine M Soltys, Montse Ferrer, Olatz Garín, Gemma Vilagut, Christoph Schürmann, Stefanie M. Thomas, Beate Wieseler, Claire Snyder, Ariel Alonso, Kris Bogaerts, Febe Brackx, Geert Molenberghs, Geert Verbeke, Cristián Frigolett Catalan, Jan Choi, Doranne Thomassen, Jan Geißler, Willi Sauerbrei, Franziska Gross, Micha J. Pilz, Yolanda Barbáchano, Lisa Campbell, Khadija Rantell, Gregoire Desplanques, Antoine Regnault, Kate Morgan, Ananda Plate, Silene ten Seldam, Mitsumi Terada, Junki Mizusawa, Sandra A. Mitchell, Ashley Wilder Smith, Tove Ragna Reksten, Anja Schiel, Kenth Louis Hansen Joseph, Alicyn Campbell, Joseph C. Cappelleri, Patrizia de Besi, Alexander Russell-Smith, Rickard Sandin, Carla Mamolo, Michael Brundage, Dongsheng Tu, Mogens Grøenvold, Morten Aagaard Petersen, C. Cleeland, Lori Williams, Xin Shelley Wang, Jolie Ringash, Melanie Calvert, Samantha Cruz Rivera, Olalekan Lee Aiyegbusi, Els Goetghebeur, Limin Liu, Kelly Van Lancker, Florien Boele, Alexandra Gilbert, Rosemary Peacock, Ethan Basch, Madeleine King, Claudia Rutherford, Vishal Bhatnagar, Mallorie H. Fiero, Erica Horodniceanu, Laura Lee Johnson, Paul G. Kluetz, Lisa Rodríguez,

Cancer survivorship and care

Patient-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.