TY - JOUR
T1 - Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI)
T2 - stakeholder views, objectives, and procedures
AU - SISAQOL-IMI Consortium
AU - Pe, Madeline
AU - Alanya, Ahu
AU - Falk, Ragnhild Sorum
AU - Amdal, Cecilie Delphin
AU - Bjordal, Kristin
AU - Chang, Jane
AU - Cislo, Paul
AU - Coens, Corneel
AU - Dirven, Linda
AU - Speck, Rebecca M.
AU - Fitzgerald, Kristina
AU - Galinsky, Jayne
AU - Giesinger, Johannes M.
AU - Holzner, Bernhard
AU - Le Cessie, Saskia
AU - O'Connor, Daniel
AU - Oliver, Kathy
AU - Pawar, Vivek
AU - Quinten, Chantal
AU - Schlichting, Michael
AU - Ren, Jinma
AU - Roychoudhury, Satrajit
AU - Taphoorn, Martin J.B.
AU - Velikova, Galina
AU - Wintner, Lisa M.
AU - Griebsch, Ingolf
AU - Bottomley, Andrew
AU - Bui, Cat
AU - Emechebe, Nnadozie
AU - Kamalakar, Rajesh
AU - Papadopoulos, Elektra
AU - Sail, Kavita
AU - Sen, Rohini
AU - Turner, Sean C.
AU - Cocks, Kim
AU - Reijneveld, Jaap
AU - Gerlinger, Christoph
AU - Keating, Karen
AU - Su, Yun
AU - Wolf, Birgit
AU - Ge, Miaomiao
AU - Ingelgaard, Anders
AU - Peil, Barbara
AU - Voorhaar, Maarten
AU - Wong, Brendon
AU - Dekanic Arbanas, Gracia
AU - Kuljanic, Karin
AU - De Vries, Corinne
AU - de Vries, Elisabeth
AU - Oosting, Sjoukje
N1 - Funding Information:
The SISAQOL-IMI project has received funding from the Innovative Medicines Initiative (IMI) 2 Joint Undertaking under grant agreement number 945052. This Joint Undertaking receives support from the EU's Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations. This Policy Review reflects the views of the individual authors and should not be construed to represent official views or policies of the European Medicines Agency, the US Food and Drug Administration, the US National Cancer Institute, Medicines and Healthcare products Regulatory Agency, Institute for Quality and Efficiency in Health Care, Health Canada, the Norwegian Medicines Agency, the American Society of Clinical Oncology, the European Society for Medical Oncology, or any other institution, organisation, or entity. This Policy Review reflects the authors’ view and that neither the IMI nor the European Federation of Pharmaceutical Industries and Associations are responsible for any use that may be made of the information contained herein.
Funding Information:
The SISAQOL-IMI project has received funding from the Innovative Medicines Initiative (IMI) 2 Joint Undertaking under grant agreement number 945052. This Joint Undertaking receives support from the EU's Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations. This Policy Review reflects the views of the individual authors and should not be construed to represent official views or policies of the European Medicines Agency, the US Food and Drug Administration, the US National Cancer Institute, Medicines and Healthcare products Regulatory Agency, Institute for Quality and Efficiency in Health Care, Health Canada, the Norwegian Medicines Agency, the American Society of Clinical Oncology, the European Society for Medical Oncology, or any other institution, organisation, or entity. This Policy Review reflects the authors’ view and that neither the IMI nor the European Federation of Pharmaceutical Industries and Associations are responsible for any use that may be made of the information contained herein.
Publisher Copyright:
© 2023 Elsevier Ltd
PY - 2023/6
Y1 - 2023/6
N2 - 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.
AB - 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.
U2 - 10.1016/S1470-2045(23)00157-2
DO - 10.1016/S1470-2045(23)00157-2
M3 - Review article
C2 - 37269858
AN - SCOPUS:85160554652
SN - 1470-2045
VL - 24
SP - e270-e283
JO - The Lancet Oncology
JF - The Lancet Oncology
IS - 6
ER -