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

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 a...

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Veröffentlicht in:	The lancet oncology 2023-06, Vol.24 (6), p.e270-e283
Hauptverfasser:	Alanya, Ahu, Falk, Ragnhild Sorum, Bjordal, Kristin, Chang, Jane, Cislo, Paul, Coens, Corneel, Dirven, Linda, Speck, Rebecca M, Fitzgerald, Kristina, Galinsky, Jayne, Giesinger, Johannes M, Holzner, Bernhard, Le Cessie, Saskia, O'Connor, Daniel, Oliver, Kathy, Quinten, Chantal, Schlichting, Michael, Ren, Jinma, Roychoudhury, Satrajit, Taphoorn, Martin J B, Velikova, Galina, Wintner, Lisa M, Bottomley, Andrew, Bui, Cat, Kamalakar, Rajesh, Sail, Kavita, Sen, Rohini, Turner, Sean C, Cocks, Kim, Su, Yun, Peil, Barbara, Voorhaar, Maarten, Wong, Brendon, Dekanic Arbanas, Gracia, Kuljanic, Karin, Rede, Ivana, Arraras, Juan, Coons, Stephen Joel, Murray, Lindsey, Pignatti, Francesco, Martinelli, Francesca, Musoro, Jammbe, Dafni, Ourania, De Vries, Elisabeth, Gyawali, Bishal, Kiesewetter, Barbara, Roitberg, Felipe, Schoepf, Felix, Tschuggnall, Michael, Sasseville, Maxime, Soltys, Katherine, Ferrer, Montserrat, Garin, Olatz, Vilagut, Gemma, Schürmann, Christoph, Wieseler, Beate, Snyder, Claire, Alonso Abad, Ariel, Bogaerts, Kris, Brackx, Febe, Molenberghs, Geert, Verbeke, Geert, Choi, Jan, Thomassen, Doranne, Geissler, Jan, Sauerbrei, Willi, Pilz, Micha Johannes, Campbell, Lisa, Rantell, Khadija, Desplanques, Gregoire, Regnault, Antoine, Morgan, Kate, Plate, Ananda, ten Seldam, Silene, Terada, Mitsumi, Mizusawa, Junki, Wilder Smith, Ashley, Reksten, Tove Ragna, Cappelleri, Joseph, de Besi, Patrizia, Russell-Smith, Alexander, Sandin, Rickard, Mamolo, Carla, Tu, Dongsheng, Petersen, Morten, Cleeland, Charlie, Williams, Lori, Calvert, Melanie, Cruz Rivera, Samantha, Aiyegbusi, Olalekan Lee, Goetghebeur, Els, Van Lancker, Kelly, Boele, Florien, Gilbert, Alexandra, Peacock, Rosemary, King, Madeleine, Bhatnagar, Vishal, Fiero, Mallorie, Johnson, Laura Lee, Rodriguez, Lisa
Format:	Artikel
Sprache:	eng
Schlagworte:	Cancer Cancer therapies Clinical outcomes Clinical trials Consensus Consortia Data analysis Data collection Decision making Humans International standards Neoplasms - drug therapy Patient Reported Outcome Measures Patients Quality of Life Risk assessment Stakeholders
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