Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/48239
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dc.contributor.authorAmdal, Cecilie D.-
dc.contributor.authorFalk, Ragnhild S.-
dc.contributor.authorAlanya, Ahu-
dc.contributor.authorSchlichting, Michael-
dc.contributor.authorRoychoudhury, Satrajit-
dc.contributor.authorBhatnagar, Vishal-
dc.contributor.authorWintner, Lisa M.-
dc.contributor.authorRegnault, Antoine-
dc.contributor.authorIngelgard, Anders-
dc.contributor.authorCoens, Corneel-
dc.contributor.authorle Cessie, Saskia-
dc.contributor.authorHolzner, Bernhard-
dc.contributor.authorChang, Jane-
dc.contributor.authorTaphoorn, Martin-
dc.contributor.authorCislo, Paul-
dc.contributor.authorGiesinger, Johannes M.-
dc.contributor.authorCappelleri, Joseph C.-
dc.contributor.authorPawar, Vivek-
dc.contributor.authorten Seldam, Silene-
dc.contributor.authorPapadopoulos, Elektra J.-
dc.contributor.authorCalvert, Melanie J.-
dc.contributor.authorJoseph, Kenth L.-
dc.contributor.authorBottomley, Andrew-
dc.contributor.authorGriebsch, Ingolf-
dc.contributor.authorArraras, Juan I.-
dc.contributor.authorAstrup, Guro L.-
dc.contributor.authorBasch, Ethan-
dc.contributor.authorBelancic, Andrej-
dc.contributor.authorBrundage, Michael-
dc.contributor.authorCampbell, Alicyn-
dc.contributor.authorRantell, Khadija Rerhou-
dc.contributor.authorCocks, Kim-
dc.contributor.authorCherny, Nathan-
dc.contributor.authorEremenco, Sonya-
dc.contributor.authorFerrer, Montse-
dc.contributor.authorFiero, Mallorie H.-
dc.contributor.authorGerlinger, Christoph-
dc.contributor.authorGOETGHEBEUR, Els-
dc.contributor.authorGrouven, Ulrich-
dc.contributor.authorLauer, Alexandra-
dc.contributor.authorAiyegbusi, Olalekan Lee-
dc.contributor.authorMachingura, Abigirl-
dc.contributor.authorMizusawa, Junki-
dc.contributor.authorMOLENBERGHS, Geert-
dc.contributor.authorPetersen, Morten Aa-
dc.contributor.authorReijneveld, Jaap C.-
dc.contributor.authorRingash, Jolie-
dc.contributor.authorRumpold, Gerhard-
dc.contributor.authorRutherford, Claudia-
dc.contributor.authorQuinten, Chantal-
dc.contributor.authorSail, Kavita-
dc.contributor.authorSasseville, Maxime-
dc.contributor.authorSauerbrei, Willi-
dc.contributor.authorSchiel, Anja-
dc.contributor.authorSmith, Ashley W.-
dc.contributor.authorSnyder, Claire-
dc.contributor.authorVelikova, Galina-
dc.contributor.authorWang , Xin S.-
dc.contributor.authorBjordal, Kristin-
dc.contributor.authorPe, Madeline-
dc.date.accessioned2026-01-23T12:22:36Z-
dc.date.available2026-01-23T12:22:36Z-
dc.date.issued2025-
dc.date.submitted2026-01-16T13:50:57Z-
dc.identifier.citationThe Lancet Oncology, 26 (12) , p. E683 -E693-
dc.identifier.urihttp://hdl.handle.net/1942/48239-
dc.description.abstractStandardising the implementation of patient-reported outcomes (PROs) in clinical trials is crucial for evaluating the benefits and risks of cancer treatments. The Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI) has developed 146 consensus-based recommendations for designing, analysing, interpreting, and presenting PROs in cancer clinical trials. This initiative, undertaken from 2021 to 2025, involved experts, including statisticians, PRO measurement experts, clinicians, and patient representatives from 41 organisations representing regulatory agencies, academia, the pharmaceutical industry, health-technology assessment bodies, and patient advocates. SISAQOL-IMI provides guidance on the implementation of PROs in randomised controlled trials and single-arm trials, terminology, definitions and the selection of PRO score interpretation thresholds, and for visualising PRO results for different audiences. To facilitate the implementation of these standards, in addition to this Policy Review, four key outputs are available: an interactive table, a guidebook, plain language materials, and a glossary.-
dc.description.sponsorshipAcknowledgments The Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical TrialsInnovative Medicines Initiative (SISAQOL-IMI) project received funding from the 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 (EFPIA). 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, US National Cancer Institute, Medicines and Healthcare products Regulatory Agency, Institute for Quality and Efficiency in Health Care, Health Canada, the Norwegian Medical Products Agency, the American Society of Clinical Oncology, the European Society for Medical Oncology, or any other institution, organisation, or entity. This project received no funding from the US National Institutes of Health. Neither the IMI nor the EU, nor EFPIA are responsible for any use that could be made of the information contained therein. We thank former work package leaders Carla Mamolo, Jinma Ren, Jayne Galinsky, Linda Dirven, and former SISAQOL-IMI Steering Committee members Daniel O’Connor and Kathy Oliver, for their invaluable efforts and dedication. We also thank Rosa Abruzzese for her extensive review and harmonisation of the language in the final deliverables of the project. Lastly, we thank Monika Turek for her help with organisational and administrative support during the entire SISAQOL-IMI project, including the submission of this Policy Review.-
dc.language.isoen-
dc.publisherELSEVIER SCIENCE INC-
dc.titleSISAQOL-IMI consensus-based guidelines to design, analyse, interpret, and present patient-reported outcomes in cancer clinical trials-
dc.typeJournal Contribution-
dc.identifier.epageE693-
dc.identifier.issue12-
dc.identifier.spageE683-
dc.identifier.volume26-
local.format.pages11-
local.bibliographicCitation.jcatA1-
dc.description.notesPe, M (corresponding author), European Org Res & Treatment Canc Headquarters, Qual Life Dept, B-1200 Brussels, Belgium.-
dc.description.notesmadeline.pe@eortc.org-
local.publisher.placeSTE 800, 230 PARK AVE, NEW YORK, NY 10169 USA-
local.type.refereedRefereed-
local.type.specifiedReview-
dc.identifier.isi001652000600001-
local.provider.typewosris-
local.description.affiliation[Amdal, Cecilie D.; Falk, Ragnhild S.; Joseph, Kenth L.; Astrup, Guro L.; Bjordal, Kristin] Oslo Univ Hosp, Oslo, Norway.-
local.description.affiliation[Alanya, Ahu; Coens, Corneel; Bottomley, Andrew; Machingura, Abigirl; Pe, Madeline] European Org Res & Treatment Canc Headquarters, Qual Life Dept, B-1200 Brussels, Belgium.-
local.description.affiliation[Schlichting, Michael] Merck Healthcare KGaA, Darmstadt, Germany.-
local.description.affiliation[Roychoudhury, Satrajit; Chang, Jane; Cislo, Paul; Cappelleri, Joseph C.] Pfizer, New York, NY USA.-
local.description.affiliation[Bhatnagar, Vishal; Fiero, Mallorie H.] US FDA, Silver Spring, MD USA.-
local.description.affiliation[Wintner, Lisa M.; Holzner, Bernhard; Giesinger, Johannes M.] Med Univ Innsbruck, Univ Hosp Psychiat 2, Innsbruck, Austria.-
local.description.affiliation[Regnault, Antoine] Modus Outcomes, Lyon, France.-
local.description.affiliation[Ingelgard, Anders; Griebsch, Ingolf; Lauer, Alexandra] Boehringer Ingelheim GmbH & Co KG, Ingelheim, Germany.-
local.description.affiliation[le Cessie, Saskia] Leiden Univ, Med Ctr, Dept Clin Epidemiol, Leiden, Netherlands.-
local.description.affiliation[Taphoorn, Martin] Leiden Univ, Med Ctr, Dept Neurol, Leiden, Netherlands.-
local.description.affiliation[Pawar, Vivek] EMD Serono, Billerica, MA USA.-
local.description.affiliation[ten Seldam, Silene] Myeloma Patients Europe, Brussels, Belgium.-
local.description.affiliation[Papadopoulos, Elektra J.; Sail, Kavita] AbbVie, Mettawa, IL USA.-
local.description.affiliation[Calvert, Melanie J.; Aiyegbusi, Olalekan Lee] Univ Birmingham, Ctr Patient Reported Outcomes Res, Birmingham, W Midlands, England.-
local.description.affiliation[Calvert, Melanie J.; Aiyegbusi, Olalekan Lee] Univ Birmingham, NIHR Biomed Res Ctr, Birmingham, W Midlands, England.-
local.description.affiliation[Arraras, Juan I.] Hosp Univ Navarra, Pamplona, Spain.-
local.description.affiliation[Basch, Ethan] Amer Soc Clin Oncol, Alexandria, VA USA.-
local.description.affiliation[Belancic, Andrej] Clin Hosp Ctr Rijeka, Rijeka, Croatia.-
local.description.affiliation[Brundage, Michael] Queens Univ Kingston, Kingston, ON, Canada.-
local.description.affiliation[Campbell, Alicyn] Patient Relevant Evidence, San Francisco, CA USA.-
local.description.affiliation[Rantell, Khadija Rerhou] Med & Healthcare Prod Regulatory Agcy, London, England.-
local.description.affiliation[Cocks, Kim] Adelphi Values, Bollington, England.-
local.description.affiliation[Cherny, Nathan] European Soc Med Oncol, Lugano, Switzerland.-
local.description.affiliation[Eremenco, Sonya] Crit Path Inst, Tucson, AZ USA.-
local.description.affiliation[Ferrer, Montse] Inst Salud Carlos III, Hosp Mar, Res Inst, Consorcio Invest Biomed Red Epidemiol & Salud Pub, Barcelona, Spain.-
local.description.affiliation[Gerlinger, Christoph] Bayer AG, Berlin, Germany.-
local.description.affiliation[Gerlinger, Christoph] Univ Med Sch Saarland, Gynaecol Obstet & Reprod Med, Homburg, Germany.-
local.description.affiliation[Goetghebeur, Els] Univ Ghent, Dept Appl Math Comp Sci & Stat, Ghent, Belgium.-
local.description.affiliation[Grouven, Ulrich] Inst Qual & Efficiency Hlth Care, Cologne, Germany.-
local.description.affiliation[Mizusawa, Junki] Natl Canc Ctr, Japan Clin Oncol Grp, Tokyo, Japan.-
local.description.affiliation[Molenberghs, Geert] Katholieke Univ Leuven, Leuven, Belgium.-
local.description.affiliation[Molenberghs, Geert] Hasselt Univ, Hasselt, Belgium.-
local.description.affiliation[Petersen, Morten Aa] Region Hovedstaden, Copenhagen, Denmark.-
local.description.affiliation[Reijneveld, Jaap C.] Amsterdam Univ Med Ctr, Amsterdam, Netherlands.-
local.description.affiliation[Ringash, Jolie] Univ Hlth Network, Toronto, ON, Canada.-
local.description.affiliation[Rumpold, Gerhard] Evaluat Software Dev, Innsbruck, Austria.-
local.description.affiliation[Rutherford, Claudia] Univ Sydney, Fac Med & Hlth, Sydney, NSW, Australia.-
local.description.affiliation[Rutherford, Claudia] Univ Sydney, Sydney Qual Life Off, Susan Wakil Sch Nursing & Midwifery, Sydney, NSW, Australia.-
local.description.affiliation[Quinten, Chantal] European Med Agcy, Amsterdam, Netherlands.-
local.description.affiliation[Sasseville, Maxime] Hlth Canada, Ottawa, ON, Canada.-
local.description.affiliation[Sauerbrei, Willi] Univ Freiburg, Fac Med, Freiburg, Germany.-
local.description.affiliation[Sauerbrei, Willi] Univ Freiburg, Med Ctr, Freiburg, Germany.-
local.description.affiliation[Schiel, Anja] Norwegian Med Prod Agcy, Oslo, Norway.-
local.description.affiliation[Smith, Ashley W.] NCI, Bethesda, MD 20892 USA.-
local.description.affiliation[Snyder, Claire] Johns Hopkins Univ, Sch Med, Baltimore, MD USA.-
local.description.affiliation[Velikova, Galina] Univ Leeds, Leeds Inst Med Res, Leeds, W Yorkshire, England.-
local.description.affiliation[Velikova, Galina] St James Hosp, Leeds Canc Ctr, Leeds, W Yorkshire, England.-
local.description.affiliation[Wang, Xin S.] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA.-
local.uhasselt.internationalyes-
item.fullcitationAmdal, Cecilie D.; Falk, Ragnhild S.; Alanya, Ahu; Schlichting, Michael; Roychoudhury, Satrajit; Bhatnagar, Vishal; Wintner, Lisa M.; Regnault, Antoine; Ingelgard, Anders; Coens, Corneel; le Cessie, Saskia; Holzner, Bernhard; Chang, Jane; Taphoorn, Martin; Cislo, Paul; Giesinger, Johannes M.; Cappelleri, Joseph C.; Pawar, Vivek; ten Seldam, Silene; Papadopoulos, Elektra J.; Calvert, Melanie J.; Joseph, Kenth L.; Bottomley, Andrew; Griebsch, Ingolf; Arraras, Juan I.; Astrup, Guro L.; Basch, Ethan; Belancic, Andrej; Brundage, Michael; Campbell, Alicyn; Rantell, Khadija Rerhou; Cocks, Kim; Cherny, Nathan; Eremenco, Sonya; Ferrer, Montse; Fiero, Mallorie H.; Gerlinger, Christoph; GOETGHEBEUR, Els; Grouven, Ulrich; Lauer, Alexandra; Aiyegbusi, Olalekan Lee; Machingura, Abigirl; Mizusawa, Junki; MOLENBERGHS, Geert; Petersen, Morten Aa; Reijneveld, Jaap C.; Ringash, Jolie; Rumpold, Gerhard; Rutherford, Claudia; Quinten, Chantal; Sail, Kavita; Sasseville, Maxime; Sauerbrei, Willi; Schiel, Anja; Smith, Ashley W.; Snyder, Claire; Velikova, Galina; Wang , Xin S.; Bjordal, Kristin & Pe, Madeline (2025) SISAQOL-IMI consensus-based guidelines to design, analyse, interpret, and present patient-reported outcomes in cancer clinical trials. In: The Lancet Oncology, 26 (12) , p. E683 -E693.-
item.accessRightsOpen Access-
item.fulltextWith Fulltext-
item.contributorAmdal, Cecilie D.-
item.contributorFalk, Ragnhild S.-
item.contributorAlanya, Ahu-
item.contributorSchlichting, Michael-
item.contributorRoychoudhury, Satrajit-
item.contributorBhatnagar, Vishal-
item.contributorWintner, Lisa M.-
item.contributorRegnault, Antoine-
item.contributorIngelgard, Anders-
item.contributorCoens, Corneel-
item.contributorle Cessie, Saskia-
item.contributorHolzner, Bernhard-
item.contributorChang, Jane-
item.contributorTaphoorn, Martin-
item.contributorCislo, Paul-
item.contributorGiesinger, Johannes M.-
item.contributorCappelleri, Joseph C.-
item.contributorPawar, Vivek-
item.contributorten Seldam, Silene-
item.contributorPapadopoulos, Elektra J.-
item.contributorCalvert, Melanie J.-
item.contributorJoseph, Kenth L.-
item.contributorBottomley, Andrew-
item.contributorGriebsch, Ingolf-
item.contributorArraras, Juan I.-
item.contributorAstrup, Guro L.-
item.contributorBasch, Ethan-
item.contributorBelancic, Andrej-
item.contributorBrundage, Michael-
item.contributorCampbell, Alicyn-
item.contributorRantell, Khadija Rerhou-
item.contributorCocks, Kim-
item.contributorCherny, Nathan-
item.contributorEremenco, Sonya-
item.contributorFerrer, Montse-
item.contributorFiero, Mallorie H.-
item.contributorGerlinger, Christoph-
item.contributorGOETGHEBEUR, Els-
item.contributorGrouven, Ulrich-
item.contributorLauer, Alexandra-
item.contributorAiyegbusi, Olalekan Lee-
item.contributorMachingura, Abigirl-
item.contributorMizusawa, Junki-
item.contributorMOLENBERGHS, Geert-
item.contributorPetersen, Morten Aa-
item.contributorReijneveld, Jaap C.-
item.contributorRingash, Jolie-
item.contributorRumpold, Gerhard-
item.contributorRutherford, Claudia-
item.contributorQuinten, Chantal-
item.contributorSail, Kavita-
item.contributorSasseville, Maxime-
item.contributorSauerbrei, Willi-
item.contributorSchiel, Anja-
item.contributorSmith, Ashley W.-
item.contributorSnyder, Claire-
item.contributorVelikova, Galina-
item.contributorWang , Xin S.-
item.contributorBjordal, Kristin-
item.contributorPe, Madeline-
crisitem.journal.issn1470-2045-
crisitem.journal.eissn1474-5488-
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