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 - 01/06/23
Doi : 10.1016/S1470-2045(23)00157-2
Madeline Pe, PhD a, ⁎ 
, Ahu Alanya, PhD b, Ragnhild Sorum Falk, PhD c, Cecilie Delphin Amdal, MD PhD c, d, Kristin Bjordal, ProfMD PhD c, e, Jane Chang, MPH f, Paul Cislo, PhD f, Corneel Coens, MSc b, Linda Dirven, PhD g, j, Rebecca M Speck, PhD k, Kristina Fitzgerald, MPH l, Jayne Galinsky, PhD m, Johannes M Giesinger, PhD n, Bernhard Holzner, ProfPhD n, Saskia Le Cessie, ProfPhD h, i, o, Daniel O’Connor, MBChB PhD p, Kathy Oliver, BA q, Vivek Pawar, PhD r, Chantal Quinten, PhD s, Michael Schlichting, MSc t, Jinma Ren, MD PhD f, Satrajit Roychoudhury, PhD f, Martin J B Taphoorn, ProfMD PhD g, j, Galina Velikova, ProfPhD u, v, Lisa M Wintner, PhD n, Ingolf Griebsch, PhD w, Andrew Bottomley, PhD b
on behalf of the
, Ahu Alanya, PhD b, Ragnhild Sorum Falk, PhD c, Cecilie Delphin Amdal, MD PhD c, d, Kristin Bjordal, ProfMD PhD c, e, Jane Chang, MPH f, Paul Cislo, PhD f, Corneel Coens, MSc b, Linda Dirven, PhD g, j, Rebecca M Speck, PhD k, Kristina Fitzgerald, MPH l, Jayne Galinsky, PhD m, Johannes M Giesinger, PhD n, Bernhard Holzner, ProfPhD n, Saskia Le Cessie, ProfPhD h, i, o, Daniel O’Connor, MBChB PhD p, Kathy Oliver, BA q, Vivek Pawar, PhD r, Chantal Quinten, PhD s, Michael Schlichting, MSc t, Jinma Ren, MD PhD f, Satrajit Roychoudhury, PhD f, Martin J B Taphoorn, ProfMD PhD g, j, Galina Velikova, ProfPhD u, v, Lisa M Wintner, PhD n, Ingolf Griebsch, PhD w, Andrew Bottomley, PhD bon behalf of the
SISAQOL-IMI Consortium
Cat Bui, Nnadozie Emechebe, Rajesh Kamalakar, Elektra Papadopoulos, Kavita Sail, Rohini Sen, Sean C Turner, Kim Cocks, Jaap Reijneveld, Christoph Gerlinger, Karen Keating, Yun Su, Birgit Wolf, Miaomiao Ge, Anders Ingelgaard, Barbara Peil, Maarten Voorhaar, Brendon Wong, Gracia Dekanic Arbanas, Karin Kuljanic, Duska Petranovic, Ivana Rede, Juan Arraras, Stephen Joel Coons, Sonya Eremenco, Lindsey Murray, Bryce Reeve, Corinne De Vries, Ralf Herold, Francesco Pignatti, Abigirl Machingura, Francesca Martinelli, Jammbe Musoro, Martine Piccart, Jorge Barriuso, Nathan Cherny, Ourania Dafni, Elisabeth De Vries, Bishal Gyawali, Barbara Kiesewetter, Sjoukje Oosting, Felipe Roitberg, Gerhard Rumpold, Felix Schoepf, Michael Tschuggnall, Jennifer Black, Maxime Sasseville, Katherine Soltys, Montserrat Ferrer, Olatz Garin, Gemma Vilagut, Christoph Schürmann, Stefanie Thomas, Beate Wieseler, Claire Snyder, Ariel Alonso Abad, Kris Bogaerts, Febe Brackx, Geert Molenberghs, Geert Verbeke, Cristián Frigolett Catalan, Jan Choi, Doranne Thomassen, Jan Geissler, Willi Sauerbrei, Franziska Gross, Micha Johannes Pilz, Yolanda Barbachano, Lisa Campbell, Khadija Rantell, Gregoire Desplanques, Antoine Regnault, Kate Morgan, Ananda Plate, Silene ten Seldam, Mitsumi Terada, Junki Mizusawa, Sandra Mitchell, Ashley Wilder Smith, Tove Ragna Reksten, Anja Schiel, Kenth Louis Hansen Joseph, Alicyn Campbell, Joseph Cappelleri, Patrizia de Besi, Alexander Russell-Smith, Rickard Sandin, Carla Mamolo, Michael Brundage, Dongsheng Tu, Mogens Groenvold, Morten Petersen, Charlie 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 Fiero, Erica Horodniceanu, Laura Lee Johnson, Paul Kluetz, Lisa Rodriguez
a Quality of Life Department, European Organisation for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium
b European Organisation for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium
c Research Support Services, Oslo University Hospital, Oslo, Norway
d Department of Oncology, Oslo University Hospital, Oslo, Norway
e Faculty of Medicine, University of Oslo, Oslo, Norway
f Pfizer, New York, NY, USA
g Department of Neurology, Leiden University Medical Center, Leiden, Netherlands
h Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, Netherlands
i Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, Netherlands
j Department of Neurology, Haaglanden Medical Center, The Hague, Netherlands
k Critical Path Institute (C-Path), Tucson, AZ, USA
l AbbVie, Mettawa, IL, USA
m Myeloma Patients Europe, Brussels, Belgium
n University Hospital of Psychiatry II, Medical University of Innsbruck, Innsbruck, Austria
o Department of Applied Mathematics, Computer Science and Statistics, Ghent University, Ghent, Belgium
p Medicines and Healthcare Products Regulatory Agency, London, UK
q International Brain Tumour Alliance, Surrey, UK
r EMD Serono, Billerica, MA, USA
s European Medicines Agency, Amsterdam, Netherlands
t Merck, Healthcare KGaA, Darmstadt, Germany
u Leeds Institute of Medical Research at St James’s, University of Leeds, St James’s University Hospital, Leeds, UK
v Leeds Cancer Centre, Leeds Teaching Hospitals NHS Trust, St James’s University Hospital, Leeds, UK
w Boehringer Ingelheim, Ingelheim am Rhein, Germany
* Correspondence to: Dr Madeline Pe, Quality of Life Department, European Organization for Research and Treatment of Cancer, Brussels 1200, Belgium Quality of Life Department European Organization for Research and Treatment of Cancer Brussels 1200 Belgium
Summary |
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.
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Vol 24 - N° 6
P. e270-e283 - juin 2023 Retour au numéro
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