TY - JOUR
T1 - Setting International Standards in Analyzing PatientReported 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 Sørum
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 - Calvert, Melanie
AU - Cruz Rivera, Samantha
AU - Aiyegbusi, Olalekan Lee
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 - Article
SN - 1470-2045
VL - 24
SP - e270-e283
JO - The Lancet Oncology
JF - The Lancet Oncology
IS - 6
ER -